Pronumbra RT-4536-HH01L

GUDID 00841439114650

Pronumbra Helping Hand, Left

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439114650
• NIH Device Record Key: fc644a7d-c505-45d0-8459-20b1209d6028
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pronumbra
• Version Model Number: RT-4536-HH01L
• Catalog Number: RT-4536-HH01L
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439114650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180021

FDA Product Code

• IXQ: Table, Radiographic, Stationary Top

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: 2025-09-22
• Device Publish Date: 2025-09-12

On-Brand Devices [Pronumbra]

• 10841439114787: Pronumbra Head, Neck & Shoulder Mask with Integrated Shim, 3.2mm Standard Perf
• 10841439114770: Pronumbra Head Only Mask with Integrated Shim, 3.2mm Standard Perf Fibreplast
• 10841439114749: Pronumbra Head, Neck & Shoulder Mask with Integrated Shim, 3.2mm Microperf Fibreplast
• 10841439114732: Pronumbra Head Only Mask with Integrated Shim, 3.2mm Microperf Fibreplast
• 00841439115138: Pronumbra 158cm kVue Package
• 00841439115121: Pronumbra 163cm Overlay Package
• 00841439115008: Pronumbra 163cm Overlay
• 00841439114995: Pronumbra 160cm kVue
• 00841439114728: Pronumbra Shoulder Adapter
• 00841439114711: Pronumbra Neck Support, 65mm
• 00841439114704: Pronumbra Neck Support, 50mm
• 00841439114698: Pronumbra Neck Support, 40mm
• 00841439114681: Pronumbra 130cm kVue
• 00841439114674: Pronumbra Helping Hand, Right
• 00841439114650: Pronumbra Helping Hand, Left