Catalog Number

OS1528

Brand Name

V. Mueller

Version/Model Number

OS1528

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

1b8d96e0-36c1-415e-b3cc-c0c677a2520a

Public Version Date

October 11, 2018

Public Version Number

1

DI Record Publish Date

September 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-