Duns Number:200564891
Device Description: 1.5 in Round Stick Sponge. X-Ray detectable.
Catalog Number
DUP2802B
Brand Name
Derma Sciences
Version/Model Number
2802B
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
39765279-aaa9-4180-a3b5-5c1e250c73c4
Public Version Date
September 24, 2021
Public Version Number
2
DI Record Publish Date
October 17, 2018
Package DI Number
00809958016824
Quantity per Package
20
Contains DI Package
00809958016817
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |