AccessGUDID - DEVICE: PreveLeak™ Surgical Sealant (00850868002025)

GUDID

Device Identifier (DI) Information

Brand Name: PreveLeak™ Surgical Sealant
Version or Model: 4 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9004
Company Name: Tenaxis Medical, Inc.

Primary DI Number: 00850868002025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783546109 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47784	Surgical internal adhesive/sealant, animal-derived	A bioabsorbable substance containing animal-derived material [e.g., bovine serum albumin (BSA)/cross-linking agent] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues (e.g., for vascular anastomosis) typically as an adjunct to standard methods of closure, to seal leaks, and might in addition be intended to achieve haemostasis through tissue sealing. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NBE	Sealant,Polymerizing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4.0 Milliliter

Device Record Status

Public Device Record Key: c5e1b80b-0004-42dc-a8bd-4ada7b6dad1e
Public Version Date: February 21, 2022
Public Version Number: 3
DI Record Publish Date: September 15, 2014