Posifix® -2 Baseplate 102021

GUDID 00841439100165

Carbon fiber baseplate for five point fixation

MEDTEC, INC.

Patient positioner base plate

• Primary Device ID: 00841439100165
• NIH Device Record Key: 850502cc-a48a-46d9-9865-56ae80948ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posifix® -2 Baseplate
• Version Model Number: 102021
• Catalog Number: 102021
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439100165 [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: 6
• Public Version Date: 2020-03-19
• Device Publish Date: 2017-08-02

On-Brand Devices [Posifix® -2 Baseplate]

• 00841439100165: Carbon fiber baseplate for five point fixation
• 00841439100158: Reusable non-sterile carbon fiber baseplate for five point fixation