| Primary Device ID | 00888233012430 |
| NIH Device Record Key | 2db77a84-d407-47c3-8909-cb1cb80d548d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | SP-1634 |
| Catalog Number | SP-1634 |
| 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 | 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 | +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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888233012430 [Primary] |
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888233012430]
Moist Heat or Steam Sterilization
[00888233012430]
Moist Heat or Steam Sterilization
[00888233012430]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2020-06-16 |