ProForm™ Thermoplastic PRO332

GUDID 20841439113107

Disposable shoulder thermoplastic (3.2 mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 20841439113107
• NIH Device Record Key: c0b8c291-9cd2-4e23-9d50-25f8f11073ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProForm™ Thermoplastic
• Version Model Number: PRO332
• Catalog Number: PRO332
• 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	00841439113103 [Primary]
GS1	10841439113100 [Package]; Contains: 00841439113103; Package: [5 Units]; In Commercial Distribution
GS1	20841439113107 [Package]; Contains: 10841439113100; Package: [4 Units]; Discontinued: 2019-10-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180021

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-18
• Device Publish Date: 2019-10-10

On-Brand Devices [ProForm™ Thermoplastic]

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• 10841439113506: IMRT FreedomView thermoplastic (3.2mm) with registration film (5)
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• 10841439113483: Head only solid with perforated nose thermoplastic (3.2mm) with registration film (5)
• 10841439113476: IMRT Clear Vision 2 open face thermoplastic (3.2mm) with registration film (5)
• 10841439113469: IMRT Clear Vision 2 open face thermoplastic (3.2mm) with registration film (5)
• 10841439113193: IMRT style 18 thermoplastic (3.2mm) with registration film (5)
• 10841439113186: Head only IMRT Clear Vision 2 open face thermoplastic (3.2mm) with registration film (5)
• 10841439113179: Head-only IMRT style 18 thermoplastic (3.2mm) with registration film (5)
• 10841439113704: IMRT Clear Vision 2 open face thermoplastic (3.2mm)
• 10841439113698: IMRT FreedomView thermoplastic (3.2mm)
• 10841439113681: IMRT Clear Vision 2 open face thermoplastic (3.2mm)
• 10841439113674: IMRT style 18 thermoplastic (3.2mm)
• 10841439113667: IMRT FreedomView thermoplastic (3.2mm)
• 10841439113650: IMRT style 18 thermoplastic (3.2mm)