Lateral Stabilizer MTIL630011

GUDID 00841439105740

For use with GE Hi-Speed CT

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439105740
• NIH Device Record Key: e657765f-cfc5-4973-9caa-61a26ae354cb
• Commercial Distribution Discontinuation: 2020-05-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Lateral Stabilizer
• Version Model Number: MTIL630011
• Catalog Number: MTIL630011
• 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: 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

Device Dimensions

• Length: 17.4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439105740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973842

FDA Product Code

• IXQ: Table, radiographic, stationary top

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-05-11
• Device Publish Date: 2017-08-02

On-Brand Devices [Lateral Stabilizer]

• 00841439105849: For use with GE VCT Global 2000 CT
• 00841439105818: For use with GE VCT Global 1700 CT
• 00841439105788: Reusable non-sterile lateral stabilizer for use with GE Discovery ST CT
• 00841439105740: For use with GE Hi-Speed CT
• 00841439105245: Reusable non-sterile lateral stabilizer for use with Siemens Somatom Sensation CT