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Crédits
Devices
CRANIOTOMY PACK
Modèle / numéro de série
Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Description du dispositif
CRANIOTOMY PACK
Manufacturer
Windstone Medical, Inc.
1 Event
Rappel de CRANIOTOMY PACK
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Fabricant
Windstone Medical, Inc.
Adresse du fabricant
Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
Source
USFDA
4 dispositifs médicaux avec un nom similaire
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Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK
Modèle / numéro de série
REF 89-7639.01 - Lot Number 24579045 REF 89-7639.01 - Lot Number 24664258 REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
(USA) including Indiana
Description du dispositif
Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
Manufacturer
DeRoyal Processing Center
CUSTOM STERILE CRANIOTOMY PACK
Modèle / numéro de série
Model Catalog: SNE30PCXXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SNE30CRXXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SBA30TF'XXX' (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SBA30FF'XXX' (Lot serial: >10 NUMBERS CONTACT MFG)
Description du dispositif
CUSTOM STERILE CRANIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.
CUSTOM STERILE CRANIOTOMY PACK
Modèle / numéro de série
Model Catalog: SNE30CRXXX (Lot serial: 02028051B); Model Catalog: SCV30VAXXX (Lot serial: 02028051B); Model Catalog: SOP30ARXXX (Lot serial: 020280903); Model Catalog: SMA30OLXXX (Lot serial: 02028051B); Model Catalog: SMA30LAXXX (Lot serial: 02028051B); Model Catalog: SLC30LPXXX (Lot serial: 02028051B); Model Catalog: SLC30LCXXX (Lot serial: 02028051B); Model Catalog: SLC30LAXXX (Lot serial: 02028051B); Model Catalog: SOP30ARXXX (Lot serial: 02028051B); Model Catalog: SMA30OSXXX (Lot serial: 02028051B); Model Catalog: SCV30CRXXX (Lot serial: 02028051B); Model Catalog: SMA30LSXXX (Lot serial: 02028051B); Model Catalog: SMA30LSXXX (Lot serial: 02028090B); Model Catalog: SAN30ABXXX (Lot serial: 02028051B); Model Catalog: SAN30ADXXX (Lot serial: 02028051B); Model Catalog: SOP30ACXXX (Lot serial: 02028051B); Model Catalog: SMA30GEXXX (Lot serial: 02028051B); Model Catalog: SBA30FFXXX (Lot serial: 02028051B); Model Catalog: SCV30CGXXX (Lot serial: 02028051B); Model Catalog: SAN30PAXXX (Lot serial: 02028051B); Mod
Description du dispositif
STERILE CRAINIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.
CUSTOM STERILE CRANIOTOMY PACK
Modèle / numéro de série
Model Catalog: SNE30CRXXX (Lot serial: 945788); Model Catalog: SEN30EAXXX (Lot serial: 887885); Model Catalog: SNE30CRXXX (Lot serial: 940554); Model Catalog: SNE30CRXXX (Lot serial: 933456); Model Catalog: SNE30CRXXX (Lot serial: 918868); Model Catalog: SNE30CRXXX (Lot serial: 900358); Model Catalog: SNE30CRXXX (Lot serial: 894055); Model Catalog: SNE30CRXXX (Lot serial: 890855); Model Catalog: SNE30CRXXX (Lot serial: 885710); Model Catalog: SNE30CRXXX (Lot serial: 953095); Model Catalog: SNE30CRXXX (Lot serial: 933512); Model Catalog: SNE30CRXXX (Lot serial: 926904); Model Catalog: SNE30CRXXX (Lot serial: 919774); Model Catalog: SNE30CRXXX (Lot serial: 909364); Model Catalog: SNE30CRXXX (Lot serial: 905131); Model Catalog: SNE30CRXXX (Lot serial: 887069); Model Catalog: SEN30MEXXX (Lot serial: 953954); Model Catalog: SEN30EAXXX (Lot serial: 953954); Model Catalog: SEN30MEXXX (Lot serial: 935731); Model Catalog: SEN30EAXXX (Lot serial: 935731); Model Catalog: SEN30MEXXX (Lot serial: 906447); Model Catalog:
Description du dispositif
STERILE CRANIOTOMY PACK
Manufacturer
CARDINAL HEALTH CANADA INC.
Language
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