C-Qual™ MT400

GUDID 00841439102640

Breastboard with head support, arm and wrist supports

MEDTEC, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00841439102640
• NIH Device Record Key: 65600bb5-472b-44c9-a18f-bd3eb1840b23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Qual™
• Version Model Number: MT400
• Catalog Number: MT400
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974703

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-12
• Device Publish Date: 2017-08-02

On-Brand Devices [C-Qual™]

• 00841439110720: Breastboard with head support
• 00841439110553: Breastboard with head support and Monarch™ Overhead Arm Positioner
• 00841439102695: Replacement support base
• 00841439102640: Breastboard with head support, arm and wrist supports