NA - Zimmer, Inc.

Duns Number:056038268

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More Product Details

Catalog Number

47-2329-019-25

Brand Name

NA

Version/Model Number

47-2329-019-25

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

Yes

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

K133246

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

d9f2d06c-9ece-47d3-a429-b54c6c52fc05

Public Version Date

July 13, 2020

Public Version Number

4

DI Record Publish Date

February 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8464
2 A medical device with a moderate to high risk that requires special controls. 20880
3 A medical device with high risk that requires premarket approval 133