PERSONA™ 42-5279-003-02
GUDID 00889024245761
Zimmer, Inc.
Knee tibia prosthesis trial| Primary Device ID | 00889024245761 |
| NIH Device Record Key | d2ed21e5-63b6-4353-8976-a08ce742f916 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERSONA™ |
| Version Model Number | 42-5279-003-02 |
| Catalog Number | 42-5279-003-02 |
| 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 | false |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024245761 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113369
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
[00889024245761]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2016-05-30 |
On-Brand Devices [PERSONA™]
| 00889024247666 | 42-5400-000-41 |
| 00889024247659 | 42-5400-000-38 |
| 00889024247642 | 42-5400-000-35 |
| 00889024247635 | 42-5400-000-32 |
| 00889024247628 | 42-5400-000-29 |
| 00889024247468 | 42-5399-061-02 |
| 00889024247451 | 42-5399-061-01 |
| 00889024247444 | 42-5399-058-02 |
| 00889024247437 | 42-5399-058-01 |
| 00889024247369 | 42-5399-023-00 |
| 00889024246089 | 42-5279-009-04 |
| 00889024246072 | 42-5279-009-03 |
| 00889024246065 | 42-5279-009-02 |
| 00889024246058 | 42-5279-009-01 |
| 00889024246041 | 42-5279-009-00 |
| 00889024245983 | 42-5279-007-04 |
| 00889024245976 | 42-5279-007-03 |
| 00889024245969 | 42-5279-007-02 |
| 00889024245952 | 42-5279-007-01 |
| 00889024245945 | 42-5279-007-00 |
| 00889024245884 | 42-5279-005-04 |
| 00889024245877 | 42-5279-005-03 |
| 00889024245860 | 42-5279-005-02 |
| 00889024245853 | 42-5279-005-01 |
| 00889024245846 | 42-5279-005-00 |
| 00889024245785 | 42-5279-003-04 |
| 00889024245778 | 42-5279-003-03 |
| 00889024245761 | 42-5279-003-02 |
| 00889024245754 | 42-5279-003-01 |
| 00889024245747 | 42-5279-003-00 |
| 00889024245686 | 42-5279-001-04 |
| 00889024245679 | 42-5279-001-03 |
| 00889024245662 | 42-5279-001-02 |
| 00889024245655 | 42-5279-001-01 |
| 00889024245648 | 42-5279-001-00 |
| 00889024245266 | 42-5272-007-10 |
| 00889024245259 | 42-5272-006-10 |
| 00889024245242 | 42-5272-005-10 |
| 00889024245235 | 42-5272-004-10 |
| 00889024245082 | 42-5270-009-19 |
| 00889024245075 | 42-5270-009-09 |
| 00889024245051 | 42-5270-007-10 |
| 00889024245044 | 42-5270-007-07 |
| 00889024245037 | 42-5270-006-10 |
| 00889024245020 | 42-5270-005-15 |
| 00889024245013 | 42-5270-005-10 |
| 00889024245006 | 42-5270-005-05 |
| 00889024244993 | 42-5270-004-10 |
| 00889024244986 | 42-5270-003-13 |
| 00889024244979 | 42-5270-003-10 |
Trademark Results [PERSONA]
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