N/A - Zimmer GmbH

Duns Number:488133448

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

75.12.92

Brand Name

N/A

Version/Model Number

75.12.92

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FZO

Product Code Name

CHISEL, SURGICAL, MANUAL

Device Record Status

Public Device Record Key

d7e21ab9-e9c2-4805-a18e-316336b6af49

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

June 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 338
2 A medical device with a moderate to high risk that requires special controls. 3101