Uni-frame® Thermoplastic MTAPUI26232

GUDID 00841439103616

Disposable non-sterile (25.4cm) IMRT Style 262 thermoplastic (3.2mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439103616
• NIH Device Record Key: 62022bb4-addd-4957-aae5-a47801a5bce2
• Commercial Distribution Discontinuation: 2019-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Uni-frame® Thermoplastic
• Version Model Number: MTAPUI26232
• Catalog Number: MTAPUI26232
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439103616 [Package]; Contains: 10841439103613; Package: [5 Units]; Discontinued: 2019-11-01; Not in Commercial Distribution
GS1	10841439103613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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: 7
• Public Version Date: 2019-11-01
• Device Publish Date: 2017-09-25

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