Encompass™ RT-B889KYSH

GUDID 00841439115091

Encompass Fibreplast Shoulder Thermoplastic

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439115091
• NIH Device Record Key: 4474e63d-aabb-42c2-92b7-02f8bc7c18b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encompass™
• Version Model Number: RT-B889KYSH
• Catalog Number: RT-B889KYSH
• 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	00841439115091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093738

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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 [Encompass™]

• 00841439115107: Encompass Shoulder Thermoplastic Adapters
• 00841439115091: Encompass Fibreplast Shoulder Thermoplastic