Duns Number:196548481
Device Description: + Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray
Catalog Number
0632-284-120
Brand Name
SURGICOUNT
Version/Model Number
0632284120
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
e44b89b3-05fa-4851-ae0c-a89f41784f33
Public Version Date
August 19, 2022
Public Version Number
4
DI Record Publish Date
July 08, 2021
Package DI Number
57613327513177
Quantity per Package
48
Contains DI Package
37613327513173
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |