| Primary Device ID | 00888233025485 |
| NIH Device Record Key | e507c505-b531-4ddc-b556-f4cff5408eed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HTR-PMI |
| Version Model Number | PM623102 |
| Company DUNS | 046189866 |
| Company Name | BIOMET MICROFIXATION, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(904)741-4400 |
| FXJAX-ORDERS@ZIMMERBIOMET.COM | |
| Phone | +1(904)741-4400 |
| FXJAX-ORDERS@ZIMMERBIOMET.COM | |
| Phone | +1(904)741-4400 |
| FXJAX-ORDERS@ZIMMERBIOMET.COM |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888233025485 [Primary] |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-08 |