Duns Number:254491293
Device Description: Reusable biopsy forceps with serrated side fenestrated jaws capable of multiple sampling. Reusable biopsy forceps with serrated side fenestrated jaws capable of multiple sampling. HIBC/UPN: M453BX910N0
Catalog Number
BX910N
Brand Name
BX Series Multi-Sampling Reusable Biopsy Forceps
Version/Model Number
BX910N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NON
Product Code Name
Forceps, Biopsy, Non-Electric, Reprocessed
Public Device Record Key
8944d601-6fe2-4d16-9b5e-99bac10d0bad
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
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 | 40 |