Duns Number:829465157
Device Description: Polyproplylene Nonabsorbable Synthetic Surgical Mesh
Catalog Number
SPM3XL
Brand Name
PROLENE
Version/Model Number
SPM3XL
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
cf86716d-60e8-4f9b-b8f3-dd0a7c5533ba
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 09, 2018
Package DI Number
20705031238821
Quantity per Package
3
Contains DI Package
10705031238824
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |