| Primary Device ID | 00841036057435 |
| NIH Device Record Key | 333c66c5-87db-442d-bd44-dcfa39d8935d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXTERNAL DISTRACTION SYSTEM |
| Version Model Number | 99-3582 |
| Catalog Number | 99-3582 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841036057435 [Primary] |
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
[00841036057435]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2015-10-11 |
| 00841036057435 | 99-3582 |
| 00841036057428 | 99-3581 |
| 00841036057411 | 99-3575 |
| 00841036057404 | 99-3572 |
| 00841036057398 | 99-3570 |
| 00841036010942 | 01-3587 |
| 00841036010935 | 01-3586 |
| 00841036010928 | 01-3585 |
| 00841036010911 | 01-3584 |
| 00841036010904 | 01-3580 |
| 00841036010850 | 01-3552 |
| 00841036010843 | 01-3551 |
| 00841036072650 | 99-5924 |
| 00841036070885 | 99-5918 |
| 00841036066796 | 99-5926 |
| 00841036011338 | 01-5926 |
| 00841036011321 | 01-5924 |
| 00841036011314 | 01-5918 |