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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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Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
In Commercial Distribution

  • 00878237001325 ()


  • Negative-pressure wound therapy open-abdomen dressing
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5
In Commercial Distribution

  • M803021005 ()
021005

  • Hygroscopic cervical dilator
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400754S1 ()
400-754S

  • Nasal cartilage support implant, non-bioabsorbable
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400654S1 ()
400-654S

  • Nasal cartilage support implant, non-bioabsorbable
Chin Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724250854S1 ()
250-854S

  • Chin prosthesis
Chin Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724250354S1 ()
250-354S

  • Chin prosthesis
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
5 Elite
In Commercial Distribution

  • 05415067020192 ()
3660

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only.
Tenaxis Medical, Inc.
5 ml
In Commercial Distribution

  • 00850868002032 ()

  • Total Volume: 5.0 Milliliter
9008

  • Surgical internal adhesive/sealant, animal-derived
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724SLUP051 ()
SLUP-05

  • Nasal cartilage support implant, non-bioabsorbable
Contoured Carving Block Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724SGRTSCM51 ()
SG-RTS-C M5

  • Silicone-block tissue reconstructive material
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