Persona® 110040839
GUDID 00889024577589
Zimmer GmbH
Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable| Primary Device ID | 00889024577589 |
| NIH Device Record Key | 10ac12fa-deb9-40d0-af2d-78814baa6e3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Persona® |
| Version Model Number | 110040839 |
| Catalog Number | 110040839 |
| Company DUNS | 488133448 |
| Company Name | Zimmer GmbH |
| 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 | 00889024577589 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212129
FDA Product Code
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
[00889024577589]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-22 |
| Device Publish Date | 2021-11-12 |
On-Brand Devices [Persona®]
Trademark Results [Persona]
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