| Primary Device ID | 00862658000326 |
| NIH Device Record Key | ee2f0fc5-32c2-495b-a452-7efcd1a2fa12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fiberoptics Technology Inc |
| Version Model Number | FTIHL |
| Company DUNS | 088324827 |
| Company Name | FIBEROPTICS TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com | |
| Phone | 8609280443 |
| tbeeman@fiberoptix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862658000326 [Primary] |
| FCT | Headlight, Fiberoptic Focusing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-03 |
| Device Publish Date | 2021-07-26 |
| 00862658000319 | Fiber Optic Medical Light Carrier |
| 00862658000302 | LO-50 LED Fiber Optic Light Source |
| 00862658000326 | Adjustable Surgical Headlight |