Duns Number:196548481
Device Description: + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring
Catalog Number
0631-108-360
Brand Name
SURGICOUNT
Version/Model Number
0631108360
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
07a75fc5-54e3-4303-b7dd-ac7d6bcbb266
Public Version Date
July 12, 2022
Public Version Number
3
DI Record Publish Date
July 08, 2021
Package DI Number
57613327512828
Quantity per Package
40
Contains DI Package
37613327512824
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 |