Catalog Number

10-1063

Brand Name

Bonopty Biopsy Set

Version/Model Number

10-1063

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"

-

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

9f6af7f2-9002-4bbc-be89-dfc10eb8e524

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

17350031350637

Quantity per Package

5

Contains DI Package

07350031350630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box