Duns Number:200564891
Device Description: 4 in X 4 in, 8-ply, 20 X 10 mesh gauze sponge, which contains an X-ray detectable monofila 4 in X 4 in, 8-ply, 20 X 10 mesh gauze sponge, which contains an X-ray detectable monofilament. Non-Sterile.
Catalog Number
DUP94408
Brand Name
Dupaque®
Version/Model Number
94408
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
727718e5-5b79-474a-b0d9-515e8383d89a
Public Version Date
September 24, 2021
Public Version Number
2
DI Record Publish Date
November 13, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |