Duns Number:631770658
Device Description: Biogel Surgeons 8.0 x 50 US
Catalog Number
-
Brand Name
Biogel® Surgeons
Version/Model Number
30480
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K053441,K053441,K053441
Product Code
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
8ef3e08c-14d7-4c36-9153-b71e50b59e7c
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
05060097931132
Quantity per Package
4
Contains DI Package
05060097930975
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 | 212 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 18 |