Combifix™ 151004MR

GUDID 00841439111895

baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and Kneefix™ cushion

MEDTEC, INC.

Radiological arm/leg positioner

• Primary Device ID: 00841439111895
• NIH Device Record Key: 03126bf6-a53b-422d-801c-e7a2d67d23b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Combifix™
• Version Model Number: 151004MR
• Catalog Number: 151004MR
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00841439111895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-19
• Device Publish Date: 2018-08-20

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