| Primary Device ID | 00880304562820 |
| NIH Device Record Key | 34c2316e-f2b3-4599-a6cd-70ab423f1777 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSEOTI RECONSTRUCTIVE WEDGE |
| Version Model Number | 597009 |
| Catalog Number | 597009 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304562820 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
[00880304562820]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-07-28 |
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| 08428898885684 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 08428898885691 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 00880304338548 - AGC ANTERIOR FILE | 2024-09-11 |
| 00880304339224 - PARALLEL PULLER | 2024-09-11 |
| 00880304342187 - AGC MODULAR TIBIAL II | 2024-09-11 |
| 00880304365247 - BIO-MODULAR | 2024-09-11 |