Collagentex Series

GUDID 00850056256445

Collagentex Rx-6 NIR device, model Rx-6, 6 lamp module

Tanses Technologies Inc

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• Primary Device ID: 00850056256445
• NIH Device Record Key: 0e73fee8-4d9f-4ae5-9df1-f1089b5059ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collagentex Series
• Version Model Number: Rx-6
• Company DUNS: 253238190
• Company Name: Tanses Technologies 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com
• Phone: 450-622-4004
• Email: info@collagentex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850056256445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180585

FDA Product Code

• NHN: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Collagentex Series ]

• 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