| Primary Device ID | 00880304375949 |
| NIH Device Record Key | ef21630f-1bfb-4dc4-b8ca-d8e177c52e7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OFFSET SADDLE IMPACTOR |
| Version Model Number | 430084 |
| Catalog Number | 430084 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | 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 | 00880304375949 [Primary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
[00880304375949]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2020-05-23 |
| 00880304009615 - BMP CABLE CUTTER | 2026-02-11 |
| 00880304387676 - OPEN END CUTTER | 2026-02-11 |
| 00887868000027 - TWIST DRILL BIT | 2026-02-11 |
| 00887868000645 - CALIBRATED TWIST DRILL | 2026-02-11 |
| 00887868048265 - EASYOUT | 2026-02-11 |
| 00887868048319 - EXTRACTION BOLT | 2026-02-11 |
| 00887868048326 - EXTRACTION BOLT | 2026-02-11 |
| 00887868048333 - EXTRACTION BOLT | 2026-02-11 |