Duns Number:967358115
Device Description: GORE SYNECOR PREPERITONEAL 9CM Circular Biomaterial
Catalog Number
GKWC09
Brand Name
GORE SYNECOR Preperitoneal Biomaterial
Version/Model Number
GKWC09
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K163576
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
2020528b-9216-4de1-b6c4-b41210fd30ec
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |