Duns Number:089055867
Device Description: DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE
Catalog Number
-
Brand Name
Durepair®
Version/Model Number
62105
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
K063117,K161370
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
365f2bfe-1a68-4df2-aaaa-cb168aca197b
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
June 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |