| Primary Device ID | 00813298027778 |
| NIH Device Record Key | 6bbb01d3-2ff1-47a2-88a8-1240849edb2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HTR-PEKK |
| Version Model Number | PK619370 |
| Company DUNS | 962301359 |
| Company Name | OXFORD PERFORMANCE MATERIALS, 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 | true |
| 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 |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com | |
| Phone | 904-741-4400 |
| fxjax-orders@biomet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813298027778 [Primary] |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
[00813298027778]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-04 |