Duns Number:023904428
Device Description: Biopsy Forceps, Kevorkian Gold Series 3 X 9.7 MM BITE 9.75 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
43-1-1482
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
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
HFB
Product Code Name
Forceps, Biopsy, Gynecological
Public Device Record Key
de9f6a7a-ea6e-4a19-a5dc-34a836630ce4
Public Version Date
December 13, 2018
Public Version Number
1
DI Record Publish Date
November 12, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |