Duns Number:305524696
Device Description: Prolapse Repair System - Anterior
Catalog Number
50100
Brand Name
Exair
Version/Model Number
50100
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
OTP
Product Code Name
Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Public Device Record Key
53de6045-aad4-47da-9d8f-e9fc2047a6eb
Public Version Date
June 10, 2022
Public Version Number
7
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 |