Duns Number:025460908
Device Description: GAUZE,SPONGE,FLUFF,7.75"X8.75",STRL,2'S
Catalog Number
NON25856
Brand Name
Medline
Version/Model Number
NON25856
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
c84c9c94-a81d-4c89-8062-236d155a692d
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 11, 2022
Package DI Number
30080196746006
Quantity per Package
25
Contains DI Package
10080196746002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |