Catalog Number

SD389135

Brand Name

NA

Version/Model Number

SD389.135

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

-

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

3650943f-62d7-4e85-b3a0-fa2cc71de898

Public Version Date

April 26, 2022

Public Version Number

3

DI Record Publish Date

December 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-