PreveLeak™ Surgical Sealant 9004

GUDID 00850868002025

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 ID: 00850868002025
• NIH Device Record Key: c5e1b80b-0004-42dc-a8bd-4ada7b6dad1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreveLeak™ Surgical Sealant
• Version Model Number: 4 ml
• Catalog Number: 9004
• Company DUNS: 783546109
• Company Name: Tenaxis Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx
• Phone: 650-691-9016
• Email: xxx@xxx.xxx

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850868002025 [Primary]

FDA Product Code

• NBE: Sealant,Polymerizing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-15

On-Brand Devices [PreveLeak™ Surgical Sealant]

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