Catalog Number

OS4331-006

Brand Name

V. Mueller

Version/Model Number

OS4331-006

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

GFI

Product Code Name

OSTEOTOME, MANUAL

Public Device Record Key

6453c9ac-5905-49d7-a041-af8f0b6b2e28

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

-