Duns Number:711789789
Device Description: DISPOSABLE HOT BIOPSY FORCEPS
Catalog Number
-
Brand Name
DISPOSABLE HOT BIOPSY FORCEPS
Version/Model Number
FD-230U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2022
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
KGE
Product Code Name
FORCEPS, BIOPSY, ELECTRIC
Public Device Record Key
10c24e69-06b2-4dfe-9c34-2432b8c940c7
Public Version Date
August 10, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
14953170158763
Quantity per Package
5
Contains DI Package
04953170158766
Package Discontinue Date
August 09, 2022
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |