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Devicor Medical Products, Inc.

United States·US-MF-000003322

Last updated September 17, 2026

About

Mammotome and Sirius Medical announce Health Canada approval for the Pintuition® System, expanding access across the country.

From the manufacturer's own website. Source

Information

Country: United States
Address: 300, E. Business Way, Cincinnati, United States
Website: www.mammotome.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: John Cummings
EUDAMED SRN: US-MF-000003322
FDA FEI Number: 3008492462
DUNS Number: —

Catalogue (273)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System	MRTRAY1	EUDAMED	Class I	Active
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System	MRFOOT1	EUDAMED	Class IIa	Active
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System	MRTARGET08	EUDAMED	Class IIa	Active
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System	MRCM1	EUDAMED	Class IIa	Active
Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System	MSMB1208	EUDAMED	Class I	Active
Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System	MSMB1210	EUDAMED	Class I	Active
Mammotome revolve	MFOOT1	FDA UDI	Class II	Active
Mammotome MR	MRK302	FDA UDI	Class II	Unknown
Mammotome MR	MRK301	FDA UDI	Class II	Unknown
neoprobe	NPB09S	FDA UDI	Class I	Active
Mammotome MicroMark II	C1535	FDA UDI	Class II	Active
HydroMark	4010-02-18-T3	FDA UDI	Class II	Active
Mammotome MicroMark II	C1540	FDA UDI	Class II	Active
Mammotome MR	MRU08X	FDA UDI	Class II	Active
HydroMark	4010-01-08-T3	FDA UDI	Class II	Unknown
HydroMark	4010-03-09-T3	FDA UDI	Class II	Active
Mammotome MAMMOMARK	MAM3001	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-01-08-S1	FDA UDI	Class II	Active
HydroMark	4010-04-09-T4	FDA UDI	Class II	Active
Mammotome	G020F	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-04-09-T1	FDA UDI	Class II	Active
Mammotome revolve	MG10B	EUDAMEDFDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-01-11-T1	FDA UDI	Class II	Active
HydroMark	4010-04-09-T3	FDA UDI	Class II	Unknown
Mammotome revolve	MST0812	EUDAMEDFDA UDI	Class II	Active
Mammotome MammoTest	G1621L	FDA UDI	Class II	Active
Mammotome	G08U	FDA UDI	Class II	Active
Mammotome Revolve EX	MCART1	FDA UDI	Class II	Active
Mammotome Revolve EX Holster	MHEXH1	EUDAMEDFDA UDI	Class II	Active
Mammotome	SCMC1	FDA UDI	Class II	Active
neoprobe	NPAF18	FDA UDI	Class I	Active
Hydromark	4010-05-08-T3	FDA UDI	Class II	Active
LumiMARK Breast Biopsy Site Marker	LM0215R	FDA UDI	Class II	Active
Mammotome	SCM12	FDA UDI	Class II	Active
Hydromark	4010-05-10-T4	FDA UDI	Class II	Active
Mammotome revolve	MST0815	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-03-15-T3-SHORT	FDA UDI	Class II	Unknown
Mammotome elite	MEH1	FDA UDI	Class II	Active
neoprobe	NPBAK	FDA UDI	Class I	Active
Mammotome	MHH11	FDA UDI	Class II	Unknown
HydroMARK Breast Biopsy Site Marker	4010-02-18-T3	FDA UDI	Class II	Active
Mammotome revolve MammoMark	MMK0801	FDA UDI	Class II	Active
Mammotome revolve	MHUS08	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-02-15-S3	FDA UDI	Class II	Unknown
HydroMark	4010-01-08-T1	FDA UDI	Class II	Unknown
HydroMark	4010-01-11-T4	FDA UDI	Class II	Unknown
Mammotome revolve	MST0809	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-03-15-T1-SHORT	FDA UDI	Class II	Unknown
neoprobe	NPCU3	FDA UDI	Class I	Unknown
Mammotome revolve	MSTH1	EUDAMEDFDA UDI	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 24, 2026	Z-2239-2026	—	open, classified	Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Mar 30, 2022	Z-1124-2022	—	terminated	Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Sep 7, 2020	Z-0070-2021	—	terminated	It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Feb 28, 2017	Z-1512-2017	—	terminated	The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
May 19, 2016	Z-2211-2016	—	terminated	A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.