Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
PREVELEAK SURGICAL SEALANT - ADS201809
Device Description
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.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NBE
Device Name: Sealant, Polymerizing
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 25413765583593
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05413765583599
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 05413765583599
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A