Persona® The Personalized Knee® System 110046018
GUDID 00889024632257
Zimmer, Inc.
Sterilization/disinfection container, reusable| Primary Device ID | 00889024632257 |
| NIH Device Record Key | 1cce6da2-7b75-40f8-815e-6559fe93737d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Persona® The Personalized Knee® System |
| Version Model Number | 110046018 |
| Catalog Number | 110046018 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024632257 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221479
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
[00889024632257]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-02 |
| Device Publish Date | 2022-11-24 |
On-Brand Devices [Persona® The Personalized Knee® System]
| 00887868554360 | 97-5026-250-00 |
| 00889024632257 | 110046018 |
| 00889024632240 | 110046017 |
| 00889024632233 | 42-5099-044-52 |
| 00889024650572 | 110047401 |
| 00889024650565 | 110047400 |
| 00889024650558 | 110047399 |
| 00889024646490 | 42-5903-070-00 |
Trademark Results [Persona]
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