Type-S™ Thermoplastic MTAPUID2032

GUDID 00841439103708

25.4cm head-only IMRT Style 20 thermoplastic (3.2mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439103708
• NIH Device Record Key: 7181067b-f11e-4605-8019-ad82a1d6ca91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Type-S™ Thermoplastic
• Version Model Number: MTAPUID2032
• Catalog Number: MTAPUID2032
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• 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	00841439103708 [Package]; Contains: 10841439103705; Package: [5 Units]; In Commercial Distribution
GS1	10841439103705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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: 2020-03-31
• Device Publish Date: 2017-09-25

On-Brand Devices [Type-S™ Thermoplastic]

• 00841439103142: Reloadable 43.2cm standard thermoplastic (2.4mm)
• 00841439110942: 25.4cm head-only IMRT Style 18 open face thermoplastic (3.2mm)
• 00841439110935: 48.3cm IMRT Style 27 open face thermoplastic (3.2mm)
• 00841439110218: 25.4cm head-only IMRT Style 18 Freedomview thermoplastic (3.2mm), Radius Bottom
• 00841439110201: 35.6cm IMRT Style 18 thermoplastic (3.2mm) Radius Bottom
• 00841439108864: Vision RT 3.2mm
• 00841439103715: 25.4cm head-only IMRT Style 22 thermoplastic (3.2mm)
• 00841439103708: 25.4cm head-only IMRT Style 20 thermoplastic (3.2mm)
• 00841439103692: 25.4cm head-only IMRT Style 20 thermoplastic (2.4mm)
• 00841439103678: 25.4cm head-only IMRT Style 18 Freedomview thermoplastic (3.2mm)
• 00841439103661: 25.4cm head-only IMRT Style 18 thermoplastic (3.2mm)
• 00841439103647: 25.4cm head-only IMRT Style 18 thermoplastic (2.4mm)
• 00841439103630: 35.6cm IMRT Style 18 thermoplastic (3.2mm)
• 00841439103623: 30.5cm IMRT Style 18 thermoplastic (3.2mm)
• 00841439103524: 25.4cm head-only standard perforated thermoplastic (2.4mm)
• 00841439103517: 35.6cm head-only standard perforated thermoplastic (2.4mm)
• 00841439103500: 30.5cm head-only standard perforated thermoplastic (2.4mm)
• 00841439103487: Head-only standard perforated thermoplastic (3.2mm)
• 00841439103364: Reloadable 43.2cm pediatric thermoplastic (2.4mm)
• 00841439103357: 48.3cm IMRT Style 29 thermoplastic (3.2mm)
• 00841439103340: 48.3cm IMRT Style 29 thermoplastic (2.4mm)
• 00841439103333: 48.3cm IMRT Style 29 thermoplastic (3.2mm)
• 00841439103326: 48.3cm IMRT Style 29 thermoplastic (2.4mm)
• 00841439103319: 48.3cm IMRT Style 27 Freedomview thermoplastic (3.2mm)
• 00841439103302: 48.3cm IMRT Style 27 thermoplastic (3.2mm)
• 00841439103296: 48.3cm IMRT Style 27 thermoplastic (2.4mm)
• 00841439103272: 48.3cm IMRT Style 27 thermoplastic (3.2mm)
• 00841439103258: 48.3cm IMRT Style 27 thermoplastic (2.4mm)
• 00841439103241: Reloadable non-sterile (43.2cm) IMRT Style 29 thermoplastic (3.2mm)
• 00841439103234: Reloadable 43.2cm IMRT Style 29 thermoplastic (3.2mm)
• 00841439103227: Reloadable non-sterile (43.2cm) IMRT Style 27 thermoplastic (3.2mm)
• 00841439103210: Reloadable non-sterile (43.2cm) IMRT Style 27 thermoplastic (2.4mm)
• 00841439103203: 43.2cm standard perforated thermoplastic (3.2mm)
• 00841439103197: 43.2cm standard perforated thermoplastic (2.4mm)
• 00841439103180: 25.4cm thermoplastic with nose perforation (2.4mm)
• 00841439103166: 43.2cm standard thermoplastic (3.2mm)
• 00841439110294: 29.6 cm standard perforated head-only thermoplastic
• 00841439107089: 48.4 cm standard perforated thermoplastic (3.2 mm)