| Primary Device ID | 00851610007299 |
| NIH Device Record Key | 5373bbb1-1df7-4db8-b470-db690348e12d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fiji Headband |
| Version Model Number | P007809 |
| Company DUNS | 030256600 |
| Company Name | LONG ISLAND TECH |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851610007299 [Primary] |
| KYT | Light, Examination, Medical, Battery Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-15 |
| Device Publish Date | 2021-06-07 |
| 00851610007220 - Pharos HD Headcam | 2021-06-15 Surgical Camera & Light |
| 00851610007299 - Fiji Headband | 2021-06-15Surgical Headlight Accessory |
| 00851610007299 - Fiji Headband | 2021-06-15 Surgical Headlight Accessory |
| 00851610007336 - Pharos HD CCU | 2021-06-15 Surgical Camera & Light |
| 00851610007190 - Dover Headlight Optic | 2020-12-29 Light, Surgical, Accessory |
| 00851610007206 - Bristol Headlight Optic | 2020-12-29 Light, Surgical, Accessory |
| 00851610007213 - Daymark Headlight Optic | 2020-12-29 Light, Surgical, Accessory |
| 00851610007268 - Dover Holster | 2020-12-29 |
| 00851610007275 - Bristol Holster | 2020-12-29 Light & Surgical Accessory |