X-PSI™ PERSONA® 20-8085-001-01
GUDID 00889024486577
Orthosoft Inc
Orthopaedic prosthesis implantation instrument, single-use| Primary Device ID | 00889024486577 |
| NIH Device Record Key | ff2b5032-155a-47b7-8bcd-0eaeff3c334f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-PSI™ PERSONA® |
| Version Model Number | 20-8085-001-01 |
| Catalog Number | 20-8085-001-01 |
| Company DUNS | 205670032 |
| Company Name | Orthosoft 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024486577 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171269
FDA Product Code
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
[00889024486577]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-04-18 |
On-Brand Devices [X-PSI™ PERSONA® ]
| 00889024486584 | 20-8085-001-02 |
| 00889024486577 | 20-8085-001-01 |
Trademark Results [X-PSI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-PSI 73541338 1405494 Dead/Cancelled |
XALOY INCORPORATED 1985-06-05 |
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