Solstice Corporation

Address:190 Sawyer Street,South Portland,ME,04106,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Film Marking, Radiographic (JAC) (4)

Premarket Exempt

Yes

Clear

Xact - 00854623006112 Catalog Number : M10TM

Device Description : Mammography lesion marker, 10mm triangle,120/box https://xactmarkers.com/pro Mammography lesion marker, 10mm triangle,120/box https://xactmarkers.com/product/lesion-markers-m10tm/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 120

Xact - 00854623006129 Catalog Number : M10R

Device Description : X-ray imaging marker for extremities, 10mm circle, 60/boxhttps://xactmarkers.com X-ray imaging marker for extremities, 10mm circle, 60/boxhttps://xactmarkers.com/product/skeletal-ring-markers-part-m10r/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 60

Xact - 00854623006136 Catalog Number : M15R

Device Description : X-ray imaging marker for extremities, 15mm circle, 60/boxhttps://xactmarkers.com X-ray imaging marker for extremities, 15mm circle, 60/boxhttps://xactmarkers.com/product/skeletal-ring-markers-m15r/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 60

Xact - 00854623006143 Catalog Number : M10AC

Device Description : Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosynthesis-area-of-concern-markers/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 80

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