Xact M15RM

GUDID 10854623006065

Mammography mole marker, 15mm circle,100/box https://xactmarkers.com/product/mole-markers-m15rm/

Solstice Corporation

Radiographic image marker, manual

• Primary Device ID: 10854623006065
• NIH Device Record Key: 6a0c45ce-c953-4f10-9723-b4fd3ad9f45b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xact
• Version Model Number: M15RM
• Catalog Number: M15RM
• Company DUNS: 609823877
• Company Name: Solstice Corporation
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com
• Phone: 800-874-7922
• Email: info@solsticecorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854623006068 [Primary]
GS1	10854623006065 [Unit of Use]

FDA Product Code

• JAC: System, X-Ray, Film Marking, Radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [Xact]

• 10854623006041: Tomo/3D imaging scar marker, 1cm perforations, 300 cm/box https://xactmarkers.com/product/tom
• 10854623006140: Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosy
• 10854623006133: X-ray imaging marker for extremities, 15mm circle, 60/box https://xactmarkers.com/product/skelet
• 10854623006126: X-ray imaging marker for extremities, 10mm circle, 60/box https://xactmarkers.com/product/skelet
• 10854623006119: Mammography lesion marker, 10mm triangle,120/box https://xactmarkers.com/product/lesion-mar
• 10854623006102: BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter,100/box http
• 10854623006096: BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 1.5mm diameter,100/box htt
• 10854623006089: X-ray metal BB marker, 2.0mm diameter, lead free,120/box https://xactmarkers.com/product/ni
• 10854623006065: Mammography mole marker, 15mm circle,100/box https://xactmarkers.com/product/mole-markers-m
• 10854623006058: Tomo/3D imaging mole marker, 15mm circle,80/box https://xactmarkers.com/product/tomography-
• 10854623006034: Mammography scar marker, 1cm perforations, 320 cm/box https://xactmarkers.com/product/scar-mark
• 10854623006027: BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.3mm diameter,85/box http
• 10854623006010: Tomo/3Dimaging lesion marker, 10mm triangle,100/box https://xactmarkers.com/product/tomograp
• 10854623006003: X-ray metal BB marker, 1.5mm diameter, lead free,120/box https://xactmarkers.com/product/ni