Duns Number:068586441
Device Description: Gauze Sponge Non-Woven N/S 4" x 4" 4-Ply, 200/Pk
Catalog Number
783044
Brand Name
Dealmed
Version/Model Number
783044
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)
-
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
71606d07-2a70-4357-9175-9bda0937d8af
Public Version Date
December 14, 2020
Public Version Number
1
DI Record Publish Date
December 04, 2020
Package DI Number
10859140003542
Quantity per Package
10
Contains DI Package
00859140003545
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 |