| Primary Device ID | 00850077007262 |
| NIH Device Record Key | d8104fec-f98c-4438-8d4b-0925ab21cdfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Huestis Centralite Patient Positioning Laser |
| Version Model Number | CTL-DLG-2214 |
| Company DUNS | 001188390 |
| Company Name | HUESTIS MACHINE CORPORATION |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com | |
| Phone | 401-253-5500 |
| sales@huestis.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850077007262 [Primary] |
| IWE | Monitor, Patient Position, Light-Beam |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-26 |
| Device Publish Date | 2021-02-18 |
| 00850077007248 | Green Diode Sagittal Laser |
| 00850077007231 | Red Diode Sagittal Laser |
| 00850077007224 | Red Diode Cross Laser |
| 00850077007217 | Green Diode Cross Laser |
| 00850077007262 | KIT CONTAINS 2 DLG-2 GREEN CROSS LASERS, 1 DLG-4 GREEN SAGITTAL LASER |
| 00850077007255 | KIT CONTAINS 2 DLL-2 RED CROSS LASERS, 1 DLL-4 RED SAGITTAL LASER |