Zimmer Biomet™ - Zimmer Surgical SA

Duns Number:481290781

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More Product Details

Catalog Number

89-8509-425-40

Brand Name

Zimmer Biomet™

Version/Model Number

89-8509-425-40

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

HAB

Product Code Name

Saw, Powered, And Accessories

Device Record Status

Public Device Record Key

6cdca417-3635-42ac-a61b-3689a36038cd

Public Version Date

July 19, 2022

Public Version Number

4

DI Record Publish Date

May 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER SURGICAL SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113