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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Mammotome HydroMARK	4010-05-10-T3	FDA UDI	Class II	Active
LumiMARK Breast Biopsy Site Marker	LM0215T	FDA UDI	Class II	Active
Hydromark	4010-05-10-T3	FDA UDI	Class II	Active
Mammotome MR	MUK304	FDA UDI	Class II	Unknown
Mammotome HydroMARK	4010-05-08-T3	FDA UDI	Class II	Active
HydroMark	4010-03-09-T3	FDA UDI	Class II	Unknown
HydroMARK Breast Biopsy Site Marker	4010-01-08-T4	FDA UDI	Class II	Active
Mammotome	MKEY1	FDA UDI	Class II	Active
Mammotome	MFSW1	FDA UDI	Class II	Active
Mammotome	MFSW1	FDA UDI	Class II	Active
Mammotome EX	HH8BEX	FDA UDI	Class II	Active
Mammotome	STHC1	FDA UDI	Class II	Active
Mammotome MR	MRU11S	FDA UDI	Class II	Active
HydroMark	4010-03-09-T1	FDA UDI	Class II	Active
HydroMARK Plus	4010-02-15-T5	FDA UDI	Class II	Active
Mammotome	G08LF	FDA UDI	Class II	Active
neoprobe	NPB14S	FDA UDI	Class I	Active
HydroMARK Breast Biopsy Site Marker	4010-04-09-T3	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-03-15-T1-SHORT	FDA UDI	Class II	Active
HydroMark	4010-04-09-S3	FDA UDI	Class II	Active
HydroMark	4010-01-11-T1	FDA UDI	Class II	Active
Hydromark	4010-05-10-T1	FDA UDI	Class II	Active
Mammotome revolve mammomark	MMK0802	FDA UDI	Class II	Active
Mammotome	G011LF	FDA UDI	Class II	Active
neoprobe	NPSW601	EUDAMEDFDA UDI	Class I	Active
Mammotome	VAS11	FDA UDI	Class II	Active
Mammotome revolve	MST1009	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-01-08-T4	FDA UDI	Class II	Unknown
Mammotome revolve MammoMark	MMK0801	FDA UDI	Class II	Active
Mammotome	Version 6.2	FDA UDI	Class II	Unknown
Mammotome	MRLB1	FDA UDI	Class II	Active
Mammotome revolve	MSCM1	EUDAMEDFDA UDI	Class II	Active
Mammotome	SCM23	FDA UDI	Class II	Active
Mammotome MicroMark II	C1535	FDA UDI	Class II	Active
Mammotome revolve	MST1009	EUDAMEDFDA UDI	Class II	Active
Mammotome revolve	MSTH1	EUDAMEDFDA UDI	Class II	Active
Mammotome	SCMC3	FDA UDI	Class II	Active
Mammotome revolve mammomark	MMK1002	FDA UDI	Class II	Active
Mammotome revolve	MST0809	EUDAMEDFDA UDI	Class II	Active
Mammotome MAMMOMARK	MAM3001	FDA UDI	Class II	Active
Mammotome revolve	MST0815	FDA UDI	Class II	Unknown
Mammotome MAMMOMARK	MRM4002	FDA UDI	Class II	Active
Mammotome Revolve	MSCM1	EUDAMEDFDA UDI	Class II	Active
Mammotome MR	MRP08X	FDA UDI	Class II	Active
Mammotome MR	MUK302	FDA UDI	Class II	Unknown
HydroMARK Breast Biopsy Site Marker	4010-02-15-T3	FDA UDI	Class II	Active
Mammotome MR	MRT08X	FDA UDI	Class II	Active
Mammotome revolve	MST1015	EUDAMEDFDA UDI	Class II	Active
Mammotome revolve	MST0812	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-01-08-S1	FDA 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.