BrachyGel Vaginal Hydrogel Packing System RT-5300

GUDID 10841439114589

BrachyGel Vaginal Hydrogel Packing System (BVHPS)

MEDTEC, INC.

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.

• 00841439115039 - Posi Indexing Bar: 2025-01-10 For use with MTM3303, MTM3304, MTM3305, MTM3004
• 00841439114858 - Headrest - TIMO Size A, B, C, D, E, F: 2024-12-12 (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B; (23.1 x 11.7 x 7.4cm) size C; (23.4 x 12.4 x 8.9cm) size D; (21.8 x
• 00841439114865 - Headrest - Timo Size A: 2024-12-12 (19.8 x 12.2 x 6.4cm)
• 00841439114872 - Headrest - Timo size B: 2024-12-12 (22.6 x 11.9 x 6.4cm)
• 00841439114889 - Headrest - Timo size C: 2024-12-12 (23.1 x 11.7 x 7.4cm)
• 00841439114896 - Headrest - Timo size D: 2024-12-12 (23.4 x 12.4 x 8.9cm)
• 00841439114902 - Headrest - Timo size E: 2024-12-12 (21.8 x 12.2 x 10.2cm)
• 00841439114919 - Headrest - Timo Size F: 2024-12-12 (23.4 x 12.2 x 9.1cm)