Posifix® Extension 108010

GUDID 00841439100400

Posifix® Extension

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439100400
• NIH Device Record Key: f0303eb6-32a6-4899-b796-cf37005c7e88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posifix® Extension
• Version Model Number: 108010
• Catalog Number: 108010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439100400 [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: 5
• Public Version Date: 2020-03-19
• Device Publish Date: 2017-08-02

On-Brand Devices [Posifix® Extension]

• 00841439110867: Reusable extension for use with Universal Couchtop™ Long Extension on Varian TrueBeam™
• 00841439110850: Reusable trUpoint ARCH™ compatible extension for use with Universal Couchtop™ Long Extension
• 00841439106471: For use with Universal Couchtop™ Long Extension
• 00841439106457: For use with Universal Couchtop™ Long Extension
• 00841439106297: Reusable non-sterile extension for use with Universal Couchtop™
• 00841439106273: Reusable non-sterile extension for use with Universal Couchtop™
• 00841439100400: Posifix® Extension