Duns Number:025460908
Device Description: GAUZE,SPONGE,2"X2",12PLY,NS,LF,8000/CS
Catalog Number
PRM21212C
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
PRM21212C
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"
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
71f199c5-db58-4e9d-bcc6-d04829092212
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 2021
Package DI Number
40080196693994
Quantity per Package
8000
Contains DI Package
20080196693990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |