| Primary Device ID | 00813110026057 |
| NIH Device Record Key | 16afdebb-a8bd-4274-a284-5173e9c80c4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotome |
| Version Model Number | 260-901-560 |
| Catalog Number | 260-901-560 |
| Company DUNS | 945015758 |
| Company Name | BICON, 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 |
| Phone | 617-524-4443 |
| support@bicon.com | |
| Phone | 617-524-4443 |
| support@bicon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813110026057 [Primary] |
| EMM | Chisel, Osteotome, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813110026057]
Moist Heat or Steam Sterilization
[00813110026057]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2016-04-08 |
| 00813110026057 | 6.0mm Osteotome |
| 00813110026040 | 5.0mm Osteotome |
| 00813110026033 | 4.5mm Osteotome |
| 00813110026026 | 4.0mm Osteotome |
| 00813110026019 | 3.5mm Osteotome |
| 00813110024176 | Osteotome Kit |