Align Fiducial Marker Kit MTNW887881

GUDID 00841439109878

Sterile placement needles (17GA ETW x 20cm) with bone wax and (1.2 x 10mm) soft tissue gold marker [2]

MEDTEC, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 00841439109878
• NIH Device Record Key: e8a15b1d-6910-4dc4-9d27-9bce74fcc6ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Align Fiducial Marker Kit
• Version Model Number: MTNW887881
• Catalog Number: MTNW887881
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439109878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071614

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

[00841439109878]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-08-02

On-Brand Devices [Align Fiducial Marker Kit]

• 00841439109892: Sterile placement needles (18GA ETW x 20cm) with bone wax and (0.8 x 10mm) soft tissue gold mark
• 00841439109885: Sterile placement needles (17GA ETW x 20cm) with bone wax and (1.2 x 10mm) soft tissue gold mark
• 00841439109878: Sterile placement needles (17GA ETW x 20cm) with bone wax and (1.2 x 10mm) soft tissue gold mark