| Primary Device ID | B2671101048K2 |
| NIH Device Record Key | bf389c30-000a-4054-af3e-3d11a7e02108 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flow-Drill™ |
| Version Model Number | 110-10-48k |
| Catalog Number | 110-10-48k |
| Company DUNS | 079293587 |
| Company Name | Flow-FX |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B2671101048K2 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-18 |
| B2671101048K2 | Flow-Drill 4.8mm Kit Shipper |
| B2671101036K2 | Flow-Drill 3.6mm Kit Shipper |
| B267110023750 | 3.6 mm Flow-Drill Guide |
| B267110010 | Ratchet Handle |
| B26711000280 | 2.8 mm Flow-Drill Guide Wire |
| B26711000200 | 2 mm Flow-Drill Guide Wire |
| B26711048K0 | Flow-Drill 4.8mm Kit |
| B26711036K0 | Flow-Drill 3.6mm Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLOW-DRILL 88260758 not registered Live/Pending |
Orthopedic Generations LLC 2019-01-14 |