Catalog Number

-

Brand Name

Sklar®

Version/Model Number

40-5793

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GFJ

Product Code Name

MALLET, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

3d17c3e3-29b8-4305-b6c4-e33e5557ca7c

Public Version Date

September 06, 2018

Public Version Number

1

DI Record Publish Date

August 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-