Duns Number:080935429
Device Description: Hydrogel Impregnated Gauze,USP Type VII Gauze Pad 0.25 oz (7 mL) Gel
Catalog Number
9255
Brand Name
Kendall
Version/Model Number
9255
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
MGQ
Product Code Name
Dressing, wound and burn, hydrogel w/drug and/or biologic
Public Device Record Key
35c0aa25-3a0b-4067-8ec3-6c9ea02381f8
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 27, 2018
Package DI Number
30884521021918
Quantity per Package
100
Contains DI Package
40884521021915
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 |