Duns Number:068586441
Device Description: Surgical Sponges Non-Sterile Woven 4" x 4" 12-Ply
Catalog Number
-
Brand Name
Dealmed Surgical Sponge
Version/Model Number
783046
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
ced18ba6-63f5-4c73-8787-449d846ee644
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 28, 2022
Package DI Number
10817415021356
Quantity per Package
10
Contains DI Package
00817415021359
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 |