Xact M15RM

GUDID 10854623006065

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

Solstice Corporation

Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual 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]

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• 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