| Primary Device ID | 00857580006386 |
| NIH Device Record Key | 5aa2d6cd-25e5-40bb-83bc-904ec939e08d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Headlight |
| Version Model Number | Lightweight, Single Back Adjustment Headgear |
| Company DUNS | 017416582 |
| Company Name | GULF FIBEROPTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 813-855-6618 |
| contact@gulffiberoptics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857580006386 [Primary] |
| FST | Light, Surgical, Fiberoptic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| 00857580006386 | A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea |
| 00857580006379 | A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea |
| 00857580006737 | A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea |