Catalog Number

250

Brand Name

Bonopty Adapter

Version/Model Number

250

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

HXY

Product Code Name

Brace, Drill

Public Device Record Key

63e2909d-7dc8-4af9-b235-e2499d913f44

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

17350031352501

Quantity per Package

5

Contains DI Package

07350031352504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box