| Primary Device ID | 00880304496835 |
| NIH Device Record Key | 54131c6a-8e79-4028-abec-8037a1d380a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARBON RAIL DEFORMITY SYSTEM |
| Version Model Number | 00042S |
| Catalog Number | 00042S |
| 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 | 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(800)348-9500 |
| customerservice@zimmerbiomet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304496835 [Primary] |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304496835]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
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| 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 |
| 00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR | 2024-09-11 |