BrachyGel Vaginal Hydrogel Packing System RT-5300

GUDID 10841439114589

BrachyGel Vaginal Hydrogel Packing System (BVHPS)

MEDTEC, INC.

Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual Vaginal brachytherapy system applicator, manual

• Primary Device ID: 10841439114589
• NIH Device Record Key: 2ec5fae5-d905-4dbb-9b25-ad1cd628959d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrachyGel Vaginal Hydrogel Packing System
• Version Model Number: RT-5300
• Catalog Number: RT-5300
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com
• Phone: +17127378688
• Email: regulatory@cqmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439114582 [Primary]
GS1	10841439114589 [Package]; Contains: 00841439114582; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220052

FDA Product Code

• QXR: Vaginal Hydrogel Packing System

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: 2024-05-31
• Device Publish Date: 2024-05-23

Devices Manufactured by MEDTEC, INC.

• 00841439114612 - Wedge: 2024-07-17 5 degree wedge, MR
• 00841439114629 - Spacer: 2024-07-17 20mm spacer, MR
• 00841439114636 - Spacer: 2024-07-17 30mm spacer, MR
• 00841439114643 - Wedge and Spacer Set: 2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR
• 10841439114589 - BrachyGel Vaginal Hydrogel Packing System: 2024-05-31BrachyGel Vaginal Hydrogel Packing System (BVHPS)
• 10841439114589 - BrachyGel Vaginal Hydrogel Packing System: 2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS)
• 00841439114599 - Pro Posifix® Headrest Adapter: 2024-05-24 Pro Posifix® Headrest Adapter
• 10841439113650 - ProForm™ Thermoplastic: 2024-02-20 IMRT style 18 thermoplastic (3.2mm)
• 10841439113667 - ProForm™ Thermoplastic: 2024-02-20 IMRT FreedomView thermoplastic (3.2mm)