Duns Number:196548481
Device Description: + Vaginal Gauze Roll, 2 inch x 2 inch, RFID, X-Ray
Catalog Number
0630-002-720
Brand Name
SURGICOUNT
Version/Model Number
0630002720
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
e25125a8-496d-46d1-9455-0ad6144ec001
Public Version Date
October 18, 2021
Public Version Number
2
DI Record Publish Date
October 07, 2021
Package DI Number
57613327513238
Quantity per Package
40
Contains DI Package
37613327513234
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 |