Duns Number:068586441
Device Description: Gauze Sponge Type VII Woven Sterile 2" x 2" 8-Ply 2's 50/Box
Catalog Number
783822
Brand Name
DEALMED
Version/Model Number
783822
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
24f0dea1-4152-4d8e-a58b-ef693cae0934
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
20817415021841
Quantity per Package
30
Contains DI Package
10817415021844
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |