Duns Number:631770658
Device Description: Biogel Diagnostic 6.0 x25 US
Catalog Number
-
Brand Name
Biogel® Diagnostic
Version/Model Number
30360
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
K971514,K971514,K971514
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
e880d0fc-1506-43d0-a0b6-eba7e9c4dba3
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
05060097937097
Quantity per Package
25
Contains DI Package
05055186413712
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
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 |