Duns Number:051798999
Device Description: C-QUR MESH, 8 in. x 10 in. (20.3 cm x 25.4 cm)
Catalog Number
-
Brand Name
C-QUR
Version/Model Number
31536
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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
K050311,K151386
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
99bdc825-6f8d-43d6-a4d3-1bbced7d98bd
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 24, 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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |