PreveLeak™ Surgical Sealant 9007

GUDID 00850868002049

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.

Surgical adhesive/sealant, animal-derived
Primary Device ID00850868002049
NIH Device Record Keyaf05c079-1976-4fe2-ab4d-25dcee854cbc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreveLeak™ Surgical Sealant
Version Model Number2.5 ml
Catalog Number9007
Company DUNS783546109
Company NameTenaxis Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx
Phone650-691-9016
Emailxxx@xxx.xxx

Device Dimensions

Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850868002049 [Primary]

FDA Product Code

NBESealant,Polymerizing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-12-31

On-Brand Devices [PreveLeak™ Surgical Sealant]

00850868002063PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed
00850868002049PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed
00850868002032PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed
00850868002025PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed

Trademark Results [PreveLeak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREVELEAK
PREVELEAK
97819898 not registered Live/Pending
Baxter International Inc.
2023-03-02
PREVELEAK
PREVELEAK
86284087 4905743 Live/Registered
BAXTER INTERNATIONAL INC.
2014-05-16
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