Duns Number:967358115
Device Description: BSGUSS45BAC ANVIL & CARTRIDGE
Catalog Number
BSGUSS45BAC
Brand Name
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
Version/Model Number
BSGUSS45BAC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043056,K043056
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
f4710da7-2510-4abc-a064-f0192d2680a1
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
February 13, 2017
Package DI Number
00733132600380
Quantity per Package
12
Contains DI Package
00733132627097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 561 |
3 | A medical device with high risk that requires premarket approval | 623 |