Duns Number:001191048
Device Description: Bard Mesh PreShaped
Catalog Number
0112700
Brand Name
Bard Mesh Pre-shaped
Version/Model Number
0112700
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
-
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
2ef0fdf3-8f92-472b-ab53-39cdee8701ee
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
April 15, 2015
Package DI Number
10801741016544
Quantity per Package
3
Contains DI Package
00801741016547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |