Duns Number:068586441
Device Description: Gauze Sponge All-Purpose Non-Woven N/S 2" x 2" 4-Ply 200/Box
Catalog Number
783222
Brand Name
Dealmed
Version/Model Number
817415020007
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
93902aa5-0ad9-4302-92f5-a902b8e5b0d3
Public Version Date
October 02, 2020
Public Version Number
2
DI Record Publish Date
September 11, 2020
Package DI Number
10817415020007
Quantity per Package
20
Contains DI Package
00817415020000
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 |