Duns Number:945385862
Device Description: Biodesign Staple Line Reinforcement
Catalog Number
C-SLRA-60
Brand Name
Biodesign
Version/Model Number
G58396
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
K201000,K201000
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
1cabe4ba-411d-41ae-94fb-3eb450ae527a
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
Package DI Number
10827002583969
Quantity per Package
4
Contains DI Package
00827002583962
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 116 |
U | Unclassified | 36 |