Posifix® -1 Baseplate 101025

GUDID 00841439109908

Reusable non-sterile narrow 1BD acrylic baseplate safe for use in MR environments (trUpoint ARCH™ compatible)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439109908
• NIH Device Record Key: b17395ff-a4a1-4ed8-9135-0cb1f2fd2254
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Posifix® -1 Baseplate
• Version Model Number: 101025
• Catalog Number: 101025
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00841439109908 [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: 2019-12-05
• Device Publish Date: 2017-08-02

On-Brand Devices [Posifix® -1 Baseplate]

• 00841439109908: Reusable non-sterile narrow 1BD acrylic baseplate safe for use in MR environments (trUpoint ARCH
• 00841439100141: Reusable non-sterile 1BD acrylic baseplate safe for use in MR environments