PERSONA®
GUDID 00889024245150
Zimmer, Inc.
Knee tibia prosthesis trial| Primary Device ID | 00889024245150 |
| NIH Device Record Key | 9b41af0c-a7be-431b-a5aa-adba4d58c630 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERSONA® |
| Version Model Number | 42-5271-007-10 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024245150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150090
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 |
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
[00889024245150]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-07-13 |
On-Brand Devices [PERSONA®]
Trademark Results [PERSONA]
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