trUpoint ARCH Replacement Kit MTHF175

GUDID 00841439104255

Disposable non-sterile putty (16), bite tray (12), nasion cushion (12) and bite cup (12) for use with trUpoint ARCH

MEDTEC, INC.

Stereotactic radiosurgical/radiotherapy arch head frame

• Primary Device ID: 00841439104255
• NIH Device Record Key: d15da8dd-0b9d-4958-bce9-690d425a98ee
• Commercial Distribution Discontinuation: 2019-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: trUpoint ARCH Replacement Kit
• Version Model Number: MTHF175
• Catalog Number: MTHF175
• 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: false
• Expiration Date: true
• 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

Device Dimensions

• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch
• Width: 3.1 Inch
• Length: 2.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132908

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: 4
• Public Version Date: 2019-03-20
• Device Publish Date: 2017-08-02

On-Brand Devices [trUpoint ARCH Replacement Kit]

• 00841439111819: Disposable non-sterile putty (6) for use with trUpoint ARCH
• 00841439111802: Disposable non-sterile bite tray (12) for use with trUpoint ARCH
• 00841439104255: Disposable non-sterile putty (16), bite tray (12), nasion cushion (12) and bite cup (12) for use