AccessGUDID - DEVICE: PREVELEAK SURGICAL SEALANT (05413765583599)

GUDID

Device Identifier (DI) Information

Brand Name: PREVELEAK SURGICAL SEALANT
Version or Model: ADS201809
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ADS201809
Company Name: Baxter Healthcare Corporation

Primary DI Number: 05413765583599
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 117472302 *Terms of Use

Device Description: Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.

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":	Yes
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 [?]
P100030	013

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
No Device Sizes

Device Record Status

Public Device Record Key: 06dda328-0214-411c-90f8-11a810010179
Public Version Date: May 15, 2025
Public Version Number: 5
DI Record Publish Date: June 01, 2021