Uni-frame® Thermoplastic MTAPU

GUDID 00841439103388

25.4cm thermoplastic (3.2mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439103388
• NIH Device Record Key: 9a1d2456-d28e-4414-891a-623578f1ca01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-frame® Thermoplastic
• Version Model Number: MTAPU
• Catalog Number: MTAPU
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439103388 [Package]; Contains: 10841439103385; Package: [5 Units]; In Commercial Distribution
GS1	10841439103385 [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: 6
• Public Version Date: 2020-04-01
• Device Publish Date: 2017-08-30

On-Brand Devices [Uni-frame® Thermoplastic]

• 00841439110225: 30.5cm extra wide IMRT perforation thermoplastic (3.2mm)
• 00841439108888: Vision RT 3.2mm wide
• 00841439108871: Reloadable, Vision RT 3.2mm
• 00841439103876: 25.4cm extra wide standard perforation thermoplastic (2.4mm)
• 00841439103869: 30.5cm extra wide standard perforation thermoplastic (2.4mm)
• 00841439103852: 25.4cm extra wide standard perforation thermoplastic (3.2mm)
• 00841439103845: Reloadable 25.4cm standard perforation thermoplastic (2.4mm)
• 00841439103838: Reloadable 35.6cm standard perforation thermoplastic (2.4mm)
• 00841439103821: Reloadable 30.5cm standard perforation thermoplastic (2.4mm)
• 00841439103807: Reloadable 25.4cm standard perforation thermoplastic (3.2mm)
• 00841439103791: Disposable non-sterile (25.4cm) standard perforated thermoplastic (3.2mm)
• 00841439103784: Reloadable 25.4cm lateral treatment thermoplastic (2.4mm)
• 00841439103777: Reloadable 25.4cm lateral treatment thermoplastic (3.2mm)
• 00841439103760: 30.5cm extra wide IMRT perforation thermoplastic (2.4mm)
• 00841439103753: Reloadable 25.4cm IMRT Style 22 thermoplastic (3.2mm)
• 00841439103746: Reloadable 25.4cm IMRT Style 20 thermoplastic (3.2mm)
• 00841439103739: 25.4cm FreedomView (3.2mm)
• 00841439103722: Reloadable 25.4cm IMRT Style 18 thermoplastic (3.2mm)
• 00841439103616: Disposable non-sterile (25.4cm) IMRT Style 262 thermoplastic (3.2mm)
• 00841439103609: 25.4cm IMRT Style 22 thermoplastic (3.2mm)
• 00841439103593: 25.4cm IMRT Style 20 thermoplastic (3.2mm)
• 00841439103586: 25.4cm IMRT Style 20 thermoplastic (2.4mm)
• 00841439103579: 25.4cm IMRT Style 18 Freedomview thermoplastic (3.2mm)
• 00841439103562: 25.4cm IMRT Style 18 thermoplastic (3.2mm)
• 00841439103555: 25.4cm head-only IMRT Style 18 ZENTEC™ thermoplastic (2.4mm)
• 00841439103548: 25.4cm IMRT Style 18 thermoplastic (2.4mm)
• 00841439103470: 25.4cm ComfortPerf® thermoplastic (3.2mm)
• 00841439103463: 25.4cm ComfortPerf® thermoplastic (2.4mm)
• 00841439103456: 25.4cm standard perforated thermoplastic (2.4mm)
• 00841439103449: 25.4cm standard perforated thermoplastic (1.6mm)
• 00841439103432: 35.6cm standard perforated thermoplastic (2.4mm)
• 00841439103425: 35.6cm standard perforated thermoplastic (1.6mm)
• 00841439103418: 35.6cm standard perforated thermoplastic (3.2mm)
• 00841439103401: 30.5cm standard perforated thermoplastic (2.4mm)
• 00841439103395: 30.5cm standard perforated thermoplastic (3.2mm)
• 00841439103388: 25.4cm thermoplastic (3.2mm)