Thermoplastic MTRFI918

GUDID 00841439107140

45.7 x 22.9cm IMRT breast support thermoplastic (3.2mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439107140
• NIH Device Record Key: c176f865-5b47-4efc-aab6-0e09dc4b41fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermoplastic
• Version Model Number: MTRFI918
• Catalog Number: MTRFI918
• 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

Device Dimensions

• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch
• Width: 9 Inch
• Length: 18 Inch

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439107140 [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: 5
• Public Version Date: 2020-04-01
• Device Publish Date: 2017-09-22

On-Brand Devices [Thermoplastic]

• 00841439103906: Disposable non-sterile (39.4 x 55.9cm) solid perforated thermoplastic (3.2mm)
• 00841439103371: Disposable non-sterile (61 x 91.4cm) standard perforated thermoplastic (2.4mm)
• 00841439103173: 3.5 x 35cm thermoplastic strip (3.2mm)
• 00841439103159: 3.5 x 25cm thermoplastic strip (3.2mm)
• 00841439107171: 45.7 x 22.9cm standard perforated breast support thermoplastic (2.4mm)
• 00841439107164: 45.7 x 22.9cm standard perforated breast support thermoplastic (3.2mm)
• 00841439107157: 45.7 x 22.9cm IMRT breast support thermoplastic (2.4mm)
• 00841439107140: 45.7 x 22.9cm IMRT breast support thermoplastic (3.2mm)
• 00841439103135: 3.5 x 61cm thermoplastic strip (3.2mm)