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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Mammotome MR	MRT11S	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-03-09-T3	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-03-09-T1	FDA UDI	Class II	Active
HydroMark	4010-02-15-T3	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-04-09-S3	FDA UDI	Class II	Active
Mammotome MR	MUK301	FDA UDI	Class II	Unknown
Mammotome revolve MammoMark	MMK0802	FDA UDI	Class II	Active
HydroMark	4010-03-15-T1-SHORT	FDA UDI	Class II	Active
Mammotome revolve	MST0812	EUDAMEDFDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-03-15-T3-SHORT	FDA UDI	Class II	Active
Mammotome revolve	MHKEYP1	FDA UDI	Class II	Active
HydroMark	4010-02-15-S3	FDA UDI	Class II	Active
Mammotome	G014F	FDA UDI	Class II	Active
Mammotome HydroMARK	4010-05-08-T1	FDA UDI	Class II	Active
Mammotome ST	MST11	FDA UDI	Class II	Active
Mammotome	VAS08	FDA UDI	Class II	Active
Mammotome MR	MUK303	FDA UDI	Class II	Unknown
HydroMARK Breast Biopsy Site Marker	4010-01-11-T3	FDA UDI	Class II	Active
neoprobe	NPE14	FDA UDI	Class I	Active
Mammotome Hydromark	4010-03-09-T1	FDA UDI	Class II	Unknown
Mammotome MAMMOMARK	MRM4008	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-02-15-T1	FDA UDI	Class II	Active
neoprobe	NPCU4	FDA UDI	Class I	Active
Mammotome	MRH1	FDA UDI	Class II	Unknown
Mammotome MAMMOMARK 2	MAM3002	FDA UDI	Class II	Active
HydroMark	4010-01-11-T3	FDA UDI	Class II	Unknown
HydroMark	4010-03-09-T1	FDA UDI	Class II	Active
Mammotome revolve	MST0815	EUDAMEDFDA UDI	Class II	Active
Mammotome	SCMSW6	FDA UDI	Class II	Active
Mammotome Revolve EX	MHEX08S	FDA UDI	Class II	Active
neoprobe	NPA71	FDA UDI	Class I	Active
Hydromark Plus	4010-02-15-T6	FDA UDI	Class II	Active
Mammotome CORMARK	MAM3014	FDA UDI	Class II	Active
HydroMark	4010-01-11-T1	FDA UDI	Class II	Unknown
HydroMark	4010-02-15-S1	FDA UDI	Class II	Active
Mammotome Hydromark	4010-03-09-T3	FDA UDI	Class II	Unknown
Mammotome revolve MammoMark	MMK1002	FDA UDI	Class II	Active
Mammotome revolve	MST1009	FDA UDI	Class II	Active
HydroMark	4010-04-09-T3	FDA UDI	Class II	Active
HydroMark	4010-04-09-T1	FDA UDI	Class II	Unknown
Mammotome revolve MammoMark	MMK1003	FDA UDI	Class II	Active
Mammotome revolve	MST1012	EUDAMEDFDA UDI	Class II	Active
Mammotome Revolve EX	MHEXHOLD1	EUDAMEDFDA UDI	Class II	Active
Mammotome	G014U	FDA UDI	Class II	Active
Mammotome	DL617	FDA UDI	Class II	Active
Mammotome MR	MRP11X	FDA UDI	Class II	Active
Mammotome ST	MST8	FDA UDI	Class II	Active
Mammotome revolve	MST1012	FDA UDI	Class II	Active
Mammotome Revolve	MHEX08	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-04-09-S3	FDA UDI	Class II	Unknown

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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.