BX Series Multi-Sampling Reusable Biopsy Forceps - Reusable biopsy forceps with serrated side - Primed Instruments Inc

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

NON

Product Code Name

Forceps, Biopsy, Non-Electric, Reprocessed

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMED INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40