Combifix™ 151003

GUDID 00841439100813

Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and low Kneefix™ cushion

MEDTEC, INC.

Radiological arm/leg positioner

• Primary Device ID: 00841439100813
• NIH Device Record Key: 3926611f-85aa-494c-90a8-8b0d6a3f2afc
• Commercial Distribution Discontinuation: 2020-01-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Combifix™
• Version Model Number: 151003
• Catalog Number: 151003
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841439100813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: 7
• Public Version Date: 2020-01-20
• Device Publish Date: 2017-08-02

On-Brand Devices [Combifix™]

• 00841439111901: baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cush
• 00841439111895: baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cush
• 00841439109953: Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfi
• 00841439109946: baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cush
• 00841439100813: Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfi
• 00841439100806: baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cush