| Primary Device ID | 00880304488380 |
| NIH Device Record Key | f33cfad2-67ea-4b2f-b64a-3dacbb12e2d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTIVAC FUSION |
| Version Model Number | 419000 |
| Catalog Number | 419000 |
| Company DUNS | 260930126 |
| Company Name | BIOMET |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | +0330475759100 |
| eufrvra@zimmerbiomet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304488380 [Primary] |
| JDZ | MIXER, CEMENT, FOR CLINICAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-09 |
| 07350023771719 - Cement Delivery System | 2021-05-05 |
| 03599870107898 - TESS BASE | 2020-10-21 |
| 03599870108505 - T.E.S.S® LID | 2020-10-21 |
| 08428898898332 - TESS BOTTOM INSERT HEMI | 2020-10-21 |
| 08428898898349 - TESS TOP INSERT HEMI | 2020-10-21 |
| 70880304810999 - Cement Delivery System | 2020-04-23 |
| 07350023771092 - Optivac Nozzle Slim | 2019-10-21 |
| 00887868214578 - BIOMET® BONE CEMENT R | 2018-07-06 |