The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Articles - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
-
Modèle / numéro de série
Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
MINOR LAPAROTOMY PACK - || (1) TABLE COVER 50" X 90" REINFORCED LIF || (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP || (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF || (5) LAP SPONGE PREWASH XRD L/F || (4) DRAPE UTILITY WITH TAPE LIF || (2) LITES GLOVE LIF || (1) TUBE SUCTION CONNECT. ~" X 12' LIF || (1) COVER MAYO STAND REINFORCED LIF || (1) UTILITY BOWL 32oz || (2) UTILITY BOWL 16oz || (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL || (1) CAUTERY TIP POLISHER LIF || (1) BLADE SURGICAL #10 CARBON STEEL || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) BAG SUTURE FLORAL || (1) DRAPE SHEET MEDIUM 41" X 69" LIF || (1) DRAPE LAP WITH POUCH SMS STD L/F || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Manufacturer
- 1 Event
Fabricant
-
Adresse du fabricant
Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
- Société-mère du fabricant (2017)
-
Source
USFDA
331 dispositifs médicaux avec un nom similaire
En savoir plus sur les données ici
-
Modèle / numéro de série
Product code 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Manufacturer
-
Modèle / numéro de série
Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
Customed O.B. Pack || convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Manufacturer
-
Modèle / numéro de série
Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Manufacturer
-
Modèle / numéro de série
Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343
- Classification du dispositif
-
Classe de dispositif
1
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Manufacturer
-
Modèle / numéro de série
Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558
- Classification du dispositif
-
Classe de dispositif
2
-
Dispositif implanté ?
No
-
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
-
Description du dispositif
Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Manufacturer