Primary Device ID | B26711000200 |
NIH Device Record Key | df563ec3-d34c-497f-960d-4a80fa750cf0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flow-Drill™ |
Version Model Number | 110-00-20 |
Catalog Number | 110-00-20 |
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 | B26711000200 [Primary] |
HWC | Screw, Fixation, Bone |
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 |