PREVELEAK SURGICAL SEALANT

Basic Information

• Brand Name: PREVELEAK SURGICAL SEALANT
• Primary DI: 05413765583582
• Version / Model: ADS201808
• Catalog Number: ADS201808
• Company Name: Baxter Healthcare Corporation
• Labeler DUNS: 117472302
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-22
• Public Version: 2
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 18d4e3c2-d829-4309-a101-e5a67e798cdd

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBE	Sealant, polymerizing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25413765583586	GS1	PACK	1	In Commercial Distribution
Primary	05413765583582	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P100030	013

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius