Duns Number:006999528
Device Description: Large Gauze Pads, all one size, 4 IN x 4 IN
Catalog Number
-
Brand Name
Kroger
Version/Model Number
041260383847
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2021
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"
Yes
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
0f48a9c6-1561-4121-8981-cab56f6e7db5
Public Version Date
September 15, 2021
Public Version Number
3
DI Record Publish Date
August 30, 2019
Package DI Number
10041260383844
Quantity per Package
72
Contains DI Package
00041260383847
Package Discontinue Date
April 27, 2021
Package Status
Not 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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |