| Primary Device ID | 00813110028075 |
| NIH Device Record Key | a40c6528-5be1-4461-9ef0-9b45b21e1fc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guided Surgery |
| Version Model Number | 260-920-380 |
| Catalog Number | 260-920-380 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813110028075 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813110028075]
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 | 2019-05-20 |
| 00813110026514 | 5.0mm Guided Surgery Rings |
| 00813110026415 | 4.5mm Guided Surgery Rings |
| 00813110026309 | 4.0mm Guided Surgery Rings |
| 00813110026149 | 3.0mm Guided Surgery Rings |
| 00813110024596 | 6.0mm Guided Surgical Kit |
| 00813110024589 | 5.0mm Guided Surgical Kit |
| 00813110024572 | 4.5mm Guided Surgical Kit |
| 00813110024565 | 4.0mm Guided Surgical Kit |
| 00813110024541 | 3.5mm Guided Surgical Kit |
| 00813110024534 | 3.0mm Guided Surgical Kit |
| 00813110028082 | 2.0 x 11.0mm Guided Pilot Drill |
| 00813110028075 | 2.0 x 8.0mm Guided Pilot Drill |
| 00813110028068 | 2.0 x 6.0mm Guided Pilot Drill |
| 00813110028051 | 2.0 x 5.0mm Guided Pilot Drill |
| 00813110028266 | 2.0mm Guided Pilot Kit |
| 00813110028044 | 2.0mm Guided Surgery Rings |