| Primary Device ID | 00850056256421 |
| NIH Device Record Key | f1a676a4-4a98-4a32-9644-d986c09b4b43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Collagentex Series |
| Version Model Number | Rx-2 |
| Company DUNS | 253238190 |
| Company Name | Tanses Technologies Inc |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com | |
| Phone | 450-622-4004 |
| info@collagentex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056256421 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-24 |
| Device Publish Date | 2023-10-16 |
| 00850056256445 | Collagentex Rx-6 NIR device, model Rx-6, 6 lamp module |
| 00850056256438 | Collagentex Rx-3 NIR device, model Rx-3, 3 lamp module |
| 00850056256421 | Collagentex Rx-2 NIR device, model Rx-2, 2 lamp module |
| 00850056256414 | Collagentex Rx-1-Seat NIR device, Seat version, model Rx-1-Seat, 1 lamp module |
| 00850056256407 | Rx-1 NIR device, model Rx-1, 1 lamp module |