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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.
4 ml
In Commercial Distribution
- 00850868002025 ()
- Total Volume: 4.0 Milliliter
9004
- Surgical internal adhesive/sealant, animal-derived
NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
In Commercial Distribution
- 00811877011538 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment.
Xvivo Perfusion AB
19033
In Commercial Distribution
- 07350069520111 ()
19033
- Lung donor-organ preservation/evaluation system lung-interface set
STENT GRAFT ETLW1613C199E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1613C199E
In Commercial Distribution
- 00643169467705 ()
- Stent Graft Distal Diameter 13 MM
- Stent Graft Covered Length 199 MM
- Stent Graft Proximal Diameter 16 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1616C156E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1616C156E
In Commercial Distribution
- 00643169467668 ()
- Stent Graft Covered Length 156 MM
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Distal Diameter 16 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1616C199E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1616C199E
In Commercial Distribution
- 00643169467651 ()
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Distal Diameter 16 MM
- Stent Graft Covered Length 199 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1610C156E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1610C156E
In Commercial Distribution
- 00643169467637 ()
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Distal Diameter 10 MM
- Stent Graft Covered Length 156 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1610C199E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1610C199E
In Commercial Distribution
- 00643169467620 ()
- Stent Graft Covered Length 199 MM
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Distal Diameter 10 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1610C93E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1610C93E
In Commercial Distribution
- 00643169467606 ()
- Stent Graft Distal Diameter 10 MM
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Covered Length 93 MM
- Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1616C82E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1616C82E
In Commercial Distribution
- 00643169467576 ()
- Stent Graft Proximal Diameter 16 MM
- Stent Graft Covered Length 82 MM
- Stent Graft Distal Diameter 16 MM
- Abdominal aorta endovascular stent-graft