SENORX, INC.

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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

MARKER, RADIOGRAPHIC, IMPLANTABLE (NEU) (6) CLIP, IMPLANTABLE (FZP) (4)

Premarket Exempt

Clear

Gel Mark Ultra™ Breast Tissue Marker - 00801741031847 Catalog Number : GMU11T

Device Description : GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, Titanium "S"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Gel Mark Ultra™ Breast Tissue Marker - 00801741031854 Catalog Number : GMUEC10GSS

Device Description : GEL MARK ULTRA™ Breast Tissue Marker, 10 Ga EnCor, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Gel Mark Ultra™ Breast Tissue Marker - 00801741031861 Catalog Number : GMUEC7GSS

Device Description : GEL MARK ULTRA™ Breast Tissue Marker, 7 Ga EnCor, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Gel Mark Ultra™ Breast Tissue Marker - 00801741031885 Catalog Number : MK2011

Device Description : GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : FZP

Prescription Use : Yes

Device Count : 1

Gel Mark UltraCor® Breast Tissue Marker - 00801741031892 Catalog Number : GMUTC005SS

Device Description : GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

Gel Mark UltraCor® Breast Tissue Marker - 00801741031908 Catalog Number : GMUTC005T

Device Description : GEL MARK ULTRACOR Marker, 14 Gauge, Titanium "S"Breast Tissue

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031915 Catalog Number : SMEC10GSS

Device Description : SENOMARK® Breast Tissue Marker, 10 Ga EnCor, SS "M"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031922 Catalog Number : SMEC12GSS

Device Description : SENOMARK® Breast Tissue Marker, 12 Ga EnCor, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031939 Catalog Number : SMEC7GSS

Device Description : SENOMARK® Breast Tissue Marker, 7 Ga EnCor, SS "M"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031946 Catalog Number : SMRSU12GT

Device Description : SENOMARK® Breast Tissue Marker, Rigid, 12 Ga ATEC, Titanium "S"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

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