Catalog Number

D242242000

Brand Name

NA

Version/Model Number

DEPD242242000

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

FZO

Product Code Name

CHISEL, SURGICAL, MANUAL

Public Device Record Key

29a65f54-9f87-4e9c-b6b2-f7e08a14892d

Public Version Date

August 14, 2019

Public Version Number

2

DI Record Publish Date

June 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-