SENORX, INC.

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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

MARKER, RADIOGRAPHIC, IMPLANTABLE (NEU) (10)

Premarket Exempt

Clear

SenoMark® Breast Tissue Marker - 00801741031953 Catalog Number : SMRSU9GT

Device Description : SENOMARK® Breast Tissue Marker, Rigid, 9 Ga ATEC, Titanium "X"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031960 Catalog Number : SMSE9GT

Device Description : SENOMARK® Breast Tissue Marker, 9 Ga Eviva, Titanium "X"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031977 Catalog Number : SMTEC10G

Device Description : SENOMARK® Breast Tissue Marker, 10 Ga EnCor, Titanium "O"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031984 Catalog Number : SMTMT11G

Device Description : SENOMARK® Breast Tissue Marker, 11 Ga Mammotome, Titanium "O"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark® Breast Tissue Marker - 00801741031991 Catalog Number : SMTSU9G

Device Description : SENOMARK® Breast Tissue Marker, 9 Ga ATEC, Titanium "O"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark UltraCor™ MRI Breast Tissue Marker - 00801741032141 Catalog Number : SMUCMRI14GSS

Device Description : SENOMARK ULTRACOR™ MRI Breast Tissue Marker, 14 Ga, SS "M"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SenoMark UltraCor™ MRI Breast Tissue Marker - 00801741032158 Catalog Number : SMUCMRI14GT

Device Description : SENOMARK ULTRACOR™ MRI Breast Tissue Marker, 14 Ga, Titanium "X"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

StarchMark® Breast Tissue Marker - 00801741032165 Catalog Number : STMKEC10GSS

Device Description : STARCHMARK® Breast Tissue Marker, 10 Ga EnCor, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

StarchMark® Breast Tissue Marker - 00801741032172 Catalog Number : STMKEC7GSS

Device Description : STARCHMARK® Breast Tissue Marker, 7 Ga EnCor, SS “V”

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

StarchMark® Breast Tissue Marker - 00801741032189 Catalog Number : STMKMT11GSS

Device Description : STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"

Device Class : 2

Duns Number: 043674543

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

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