Solstice Corporation

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

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Filters

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) (10)

Premarket Exempt

Yes

Clear

Xact - 00854623006006 Catalog Number : M15S

Device Description : X-ray metal BB marker, 1.5mm diameter, lead free,120/box https://xactmarkers X-ray metal BB marker, 1.5mm diameter, lead free,120/box https://xactmarkers.com/product/nipple-markers-bb-markers-for-radiology-m15s/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 120

Xact - 00854623006013 Catalog Number : M10TT

Device Description : Tomo/3Dimaging lesion marker, 10mm triangle,100/box https://xactmarkers.com/p Tomo/3Dimaging lesion marker, 10mm triangle,100/box https://xactmarkers.com/product/tomography-lesion-markers-2/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 100

Xact - 00854623006020 Catalog Number : M23SC

Device Description : BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.3mm diameter, BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.3mm diameter,85/box https://xactmarkers.com/product/bb-markers-for-ct-m23sc/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 85

Xact - 00854623006037 Catalog Number : M10LM

Device Description : Mammography scar marker, 1cm perforations, 320 cm/box https://xactmarkers.com/pr Mammography scar marker, 1cm perforations, 320 cm/box https://xactmarkers.com/product/scar-markers-m10lm/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 320

Xact - 00854623006044 Catalog Number : M10LT

Device Description : Tomo/3D imaging scar marker, 1cm perforations, 300 cm/box https://xactmarkers. Tomo/3D imaging scar marker, 1cm perforations, 300 cm/box https://xactmarkers.com/product/tomography-scar-markers/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 300

Xact - 00854623006051 Catalog Number : M15RT

Device Description : Tomo/3D imaging mole marker, 15mm circle,80/box https://xactmarkers.com/prod Tomo/3D imaging mole marker, 15mm circle,80/box https://xactmarkers.com/product/tomography-mole-markers/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 80

Xact - 00854623006068 Catalog Number : M15RM

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

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 100

Xact - 00854623006082 Catalog Number : M20S

Device Description : X-ray metal BB marker, 2.0mm diameter, lead free,120/box https://xactmarkers X-ray metal BB marker, 2.0mm diameter, lead free,120/box https://xactmarkers.com/product/nipple-markers-bb-markers-for-radiology-m20s/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 120

Xact - 00854623006099 Catalog Number : M15SC

Device Description : BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 1.5mm diameter, BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 1.5mm diameter,100/box https://xactmarkers.com/product/1-5mm-tomosynthesisct-bb-markers/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 100

Xact - 00854623006105 Catalog Number : M20SC

Device Description : BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter, BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter,100/box https://xactmarkers.com/product/2-0mm-tomosynthesisct-bb-markers/

Device Class : 1

Duns Number: 609823877

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : No

Device Count : 100

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