PERSONA™ - Zimmer, Inc.

Duns Number:056038268

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More Product Details

Catalog Number

42-5110-004-13

Brand Name

PERSONA™

Version/Model Number

42-5110-004-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K113369,K172524

Product Code Details

Product Code

JWH

Product Code Name

PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Device Record Status

Public Device Record Key

27a6891b-1f16-4834-8189-07a3e8bba2e9

Public Version Date

November 14, 2019

Public Version Number

4

DI Record Publish Date

September 17, 2015

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