Duns Number:080935429
Device Description: Bandage Roll,100% Cotton, 6 Ply, Medium
Catalog Number
6725
Brand Name
Kerlix
Version/Model Number
6725
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
37ec6fbf-75e1-42ec-b92c-ec1cf50eae6e
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
June 29, 2018
Package DI Number
10884521058484
Quantity per Package
96
Contains DI Package
00884521058487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |