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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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Contoured Carving Block Style 1
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724CCB151 ()
CCB1-5

  • Silicone-block tissue reconstructive material
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
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
No Description
PHARMACEUTICAL HEALTH LIMITED
5 Count
In Commercial Distribution

  • 5060497630055 ()
  • 05060497630048 ()


  • Synovial fluid supplementation medium
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
In Commercial Distribution

  • 00868201000171 ()
131133-05-S

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial
No Description
Merete GmbH
right 5
In Commercial Distribution

  • 04048266135896 ()

  • Wedge 5 mm
FH13005

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Merete GmbH
left 5
In Commercial Distribution

  • 04048266135865 ()

  • Wedge 5 mm
FH12005

  • Orthopaedic fixation plate, non-bioabsorbable
TI ECCENTER-STERILE
SYNTHES (U.S.A.) LP
5413-20/5
Not in Commercial Distribution

  • H67954132050 ()
  • 10886982241313 ()
5413205

  • Shoulder humeral body prosthesis
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