Device Recall Integra

  • Modèle / numéro de série
    W1003222, W1005153, W1006110, W1010082, W1103148, W1108088, W1108227.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution
  • Description du dispositif
    Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. || Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Société-mère du fabricant (2017)
  • Source
    USFDA

85 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Serial numbers: 2-381
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
  • Description du dispositif
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 || Product Usage: || The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
  • Manufacturer
  • Modèle / numéro de série
    Catalogue No's:  CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B, CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120. All batch numbers distributed from January 2011 to February 17, 2016.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
  • Description du dispositif
    Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
  • Manufacturer
  • Modèle / numéro de série
    Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
  • Description du dispositif
    Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
  • Manufacturer
  • Modèle / numéro de série
    Catalogue No. MIDRT 8101 Lot No. 105A00324750
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to PA
  • Description du dispositif
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only || Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient || Manufactured by: || Integra LifeSciences Corporation || 311 Enterprise Drive, Plainsboro, NJ 08536 || 877-444-1122 USA n 609-936-5400 outside USA || 866-800-7742 fax
  • Manufacturer
  • Modèle / numéro de série
    Lot # PN625.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
  • Description du dispositif
    Integra External Fixation System Rocker Bottom Model # 12225400. || For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
  • Manufacturer
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