PERSONA® Natural Tibia® 42-5321-083-01
GUDID 00889024595880
Zimmer, Inc.
Knee tibia prosthesis trial| Primary Device ID | 00889024595880 |
| NIH Device Record Key | f1fe5ecd-b9e3-4498-aae2-e5bc7f6c1f8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERSONA® Natural Tibia® |
| Version Model Number | 42-5321-083-01 |
| Catalog Number | 42-5321-083-01 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024595880 [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 |
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
[00889024595880]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2021-01-20 |
On-Brand Devices [PERSONA® Natural Tibia®]
| 00889024501157 | 110035802 |
| 00889024501140 | 110035800 |
| 00889024203990 | 00-5907-081-45 |
| 00889024203969 | 00-5907-081-42 |
| 00889024595897 | 42-5321-083-02 |
| 00889024595880 | 42-5321-083-01 |
| 00889024595873 | 42-5321-079-02 |
| 00889024595866 | 42-5321-079-01 |
| 00889024595859 | 42-5321-075-02 |
| 00889024595842 | 42-5321-075-01 |
| 00889024595835 | 42-5321-071-02 |
| 00889024595828 | 42-5321-071-01 |
| 00889024595811 | 42-5321-067-02 |
| 00889024595804 | 42-5321-067-01 |
| 00889024595781 | 42-5321-064-01 |
| 00889024595798 | 42-5321-064-02 |
Trademark Results [PERSONA]
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