Uni-frame® Baseplate MT20108

GUDID 00841439102428

Standard baseplate for use with Accuray®

MEDTEC, INC.

Patient positioner base plate

• Primary Device ID: 00841439102428
• NIH Device Record Key: 5a9594d0-18a6-4008-a287-92ea72c40d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-frame® Baseplate
• Version Model Number: MT20108
• Catalog Number: MT20108
• 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: 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	00841439102428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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 [Uni-frame® Baseplate]

• 00841439102428: Standard baseplate for use with Accuray®
• 00841439102411: Tilting baseplate
• 00841439102404: Tilting baseplate assembly kit
• 00841439102398: tilting baseplate
• 00841439102381: standard baseplate
• 00841439102374: Standard baseplate