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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a wound-down insert and a valved introducer.
Bayer Healthcare LLC
ESS305 (Kit)
Not in Commercial Distribution

  • 20888853003058 ()


  • Fallopian tube occlusion insert, non-biodegradable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-55001nc
In Commercial Distribution

  • 08800039102254 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-47501nc
In Commercial Distribution

  • 08800039102216 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-55001c
In Commercial Distribution

  • 08800039101035 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAPN-47501c
In Commercial Distribution

  • 08800039101028 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAP-55001ca
In Commercial Distribution

  • 08800039100601 ()


  • Tendon/ligament bone anchor, bioabsorbable
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
AJU PHARM. CO., LTD.
KAP-47501ca
In Commercial Distribution

  • 08800039100571 ()


  • Tendon/ligament bone anchor, bioabsorbable
A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.
INVOTEC INTERNATIONAL, INC.
001
In Commercial Distribution

  • 00818501020010 ()
20-10400S

  • Nasal septal button
A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.
INVOTEC INTERNATIONAL, INC.
001
In Commercial Distribution

  • 00818501020003 ()
20-10400

  • Nasal septal button
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP11216
Not in Commercial Distribution

  • M268BP112160 ()
  • 10381780074250 ()

  • Length: 12 Centimeter
  • Width: 16 Centimeter
BP11216

  • Dura mater graft, bovine
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