Duns Number:008124539
Device Description: Sterile Surgical Sponge, 4"x4", 12-ply, 10s, All Gauze
Catalog Number
-
Brand Name
Sterile Surgical Sponges
Version/Model Number
3345
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
0f91b3ca-46e4-47f1-89c8-9a1b5c774974
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
00616784334530
Quantity per Package
128
Contains DI Package
00616784334516
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |