Coupled™ Fiducial Marker Kit MTNW887710

GUDID 00841439109601

Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker coupled with 17mm spacer and (1.0 x 3mm) soft tissue gold marker

MEDTEC, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 00841439109601
• NIH Device Record Key: 3c054c85-98cf-40ad-a3f3-2adfe8cfd87f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coupled™ Fiducial Marker Kit
• Version Model Number: MTNW887710
• Catalog Number: MTNW887710
• 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	00841439109601 [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

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

Ethylene Oxide

[00841439109601]

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 [Coupled™ Fiducial Marker Kit]

• 00841439109625: Sterile placement needles (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker c
• 00841439109618: Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker co
• 00841439109601: Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker co
• 00841439109595: Sterile placement needles (18GA ETW x 20cm) with bone wax, (0.8 x 3mm) soft tissue gold marker c