| Primary Device ID | 00854515008149 |
| NIH Device Record Key | 9327bdab-8a41-4142-ab26-aef8147eb8f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IM Rod |
| Version Model Number | Flexible |
| Catalog Number | 1167 |
| Company DUNS | 079820535 |
| Company Name | Unique Surgical |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 818-813-8527 |
| info@UniqueSurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854515008149 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00854515008149]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-01-13 |
| Device Publish Date | 2023-01-05 |
| 00854515008385 - Tibial Cutting Jig | 2023-06-30 |
| 00854515008323 - Patella Clamp | 2023-05-03 |
| 00854515008361 - Alignment Guide | 2023-05-03 |
| 00854515008101 - Lima Femoral Cutting Block | 2023-01-13 |
| 00854515008132 - Lima Femoral Cutting Block | 2023-01-13 |
| 00854515008149 - IM Rod | 2023-01-13 |
| 00854515008149 - IM Rod | 2023-01-13 |
| 00854515008156 - T-Handle | 2023-01-13 |
| 00854515008231 - Angled Drill Bit | 2023-01-13 |