Duns Number:025460908
Device Description: GAUZE,SPONGE,USP,4"X4",12PLY,STRL,10/PK
Catalog Number
PRM21426
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
PRM21426
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
65d0ca24-47d0-433f-b292-c56f0dfd38ca
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2021
Package DI Number
40080196326540
Quantity per Package
128
Contains DI Package
20080196326546
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 | 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 |