Duns Number:305524696
Device Description: Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - L
Catalog Number
501440
Brand Name
Restorelle
Version/Model Number
501440
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
OTO
Product Code Name
Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Public Device Record Key
802aa5e9-c5db-4f48-b4ba-d21ab50c3a21
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 22, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |