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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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t:slim X2 5.0 Insulin Pump
Tandem Diabetes Care, Inc.
1000885
In Commercial Distribution

  • 00853052007257 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim G4 / X2 Cartridge, t:lock, 2 Pack
Tandem Diabetes Care, Inc.
1000728
In Commercial Distribution

  • 00853052007233 ()
  • 00853052007547 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir
t:slim G4 / X2 Cartridge, t:lock, 10 Pack
Tandem Diabetes Care, Inc.
1000727
In Commercial Distribution

  • 00853052007226 ()
  • 00853052007547 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir
12 mm Synthetic Cartilage Implant
CARTIVA, INC
CAR-12-US
Not in Commercial Distribution

  • 00852897002335 ()
CAR-12-US

  • Total metatarsophalangeal joint prosthesis, one-piece
6 mm Synthetic Cartilage Implant
CARTIVA, INC
CAR-06-US
Not in Commercial Distribution

  • 00852897002328 ()
CAR-06-US

  • Total metatarsophalangeal joint prosthesis, one-piece
10 mm Synthetic Cartilage Implant
CARTIVA, INC
CAR-10-US
Not in Commercial Distribution

  • 00852897002038 ()
CAR-10-US

  • Total metatarsophalangeal joint prosthesis, one-piece
8 mm Synthetic Cartilage Implant
CARTIVA, INC
CAR-08-US
Not in Commercial Distribution

  • 00852897002021 ()
CAR-08-US

  • Total metatarsophalangeal joint prosthesis, one-piece
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.
2.5 ml
In Commercial Distribution

  • 00850868002063 ()

  • Total Volume: 2.5 Milliliter
9007

  • Surgical internal adhesive/sealant, animal-derived
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.
2.5 ml
In Commercial Distribution

  • 00850868002049 ()

  • Total Volume: 2.5 Milliliter
9007

  • Surgical internal adhesive/sealant, animal-derived
Local Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-500
Not in Commercial Distribution

  • 00851551005194 ()


  • Microwave hyperthermia system
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