Catalog Number

141-096

Brand Name

Ambler Value Line

Version/Model Number

Cottle mallet

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

GFJ

Product Code Name

MALLET, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

a394dd67-4af0-407a-99da-2c07cfa26df7

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-