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Sign in to claim this brandDevicor 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- John Cummings
- EUDAMED SRN
- US-MF-000003322
- FDA FEI Number
- 3008492462
- DUNS Number
- —
Catalogue (273)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mammotome revolve mammomark | MMK1001 | FDA UDI | Class II | Active |
| Mammotome | MHH11B | FDA UDI | Class II | Unknown |
| HydroMARK Breast Biopsy Site Marker | 4010-02-15-S3 | FDA UDI | Class II | Active |
| Mammotome revolve | MST1015 | FDA UDI | Class II | Active |
| Mammotome revolve | MHUSH1 | EUDAMEDFDA UDI | Class II | Active |
| Mammotome | G014LF | FDA UDI | Class II | Active |
| Mammotome MR | MRP08S | FDA UDI | Class II | Active |
| HydroMark | 4010-03-15-T3-SHORT | FDA UDI | Class II | Active |
| HydroMARK Breast Biopsy Site Marker | 4010-01-08-T1 | FDA UDI | Class II | Active |
| HydroMark | 4010-02-15-S1 | FDA UDI | Class II | Unknown |
| HydroMARK Breast Biopsy Site Marker | 4010-02-15-S1 | FDA UDI | Class II | Active |
| HydroMARK Breast Biopsy Site Marker | 4010-01-11-T4 | FDA UDI | Class II | Active |
| HydroMARK | 4010-05-08-T1 | FDA UDI | Class II | Active |
| Mammotome MR | MRU08S | FDA UDI | Class II | Active |
| Mammotome MAMMOMARK 2 | MAM3008 | FDA UDI | Class II | Active |
| Mammotome revolve | MG10A | EUDAMEDFDA UDI | Class II | Active |
| Mammotome MR | MRT08S | FDA UDI | Class II | Active |
| Neoprobe | NPB10S | FDA UDI | Class I | Active |
| Mammotome | STCH1 | FDA UDI | Class II | Active |
| HydroMARK Breast Biopsy Site Marker | 4010-04-09-T4 | FDA UDI | Class II | Active |
| HydroMark | 4010-02-15-T1 | FDA UDI | Class II | Unknown |
| Mammotome revolve | MCART1 | FDA UDI | Class II | Active |
| HydroMark | 4010-01-08-T1 | FDA UDI | Class II | Active |
| HydroMark | 4010-01-11-T4 | FDA UDI | Class II | Active |
| Mammotome MR | MRK304 | FDA UDI | Class II | Unknown |
| Mammotome revolve MammoMark | MMK0803 | FDA UDI | Class II | Active |
| Mammotome ST | MST14 | FDA UDI | Class II | Active |
| Mammotome MAMMOMARK | MRM4002 | FDA UDI | Class II | Active |
| HydroMark | 4010-02-15-T4 | FDA UDI | Class II | Active |
| HydroMARK | 4010-05-08-T3 | FDA UDI | Class II | Active |
| Mammotome revolve | MHUS10 | EUDAMEDFDA UDI | Class II | Active |
| Mammotome HydroMARK | 4010-05-10-T1 | FDA UDI | Class II | Active |
| HydroMark | 4010-01-11-T3 | FDA UDI | Class II | Active |
| Mammotome revolve | MHUS08 | EUDAMEDFDA UDI | Class II | Active |
| HydroMark | 4010-02-18-T3 | FDA UDI | Class II | Unknown |
| Mammotome MR | MRT11X | FDA UDI | Class II | Active |
| neoprobe | NEOCART1 | FDA UDI | Class I | Active |
| Mammotome | SCMC3 | FDA UDI | Class II | Active |
| Mammotome MR | MRU11X | FDA UDI | Class II | Active |
| Mammotome revolve | MG08B | EUDAMEDFDA UDI | Class II | Active |
| Mammotome revolve | MG08A | EUDAMEDFDA UDI | Class II | Active |
| HydroMARK Breast Biopsy Site Marker | 4010-01-08-T3 | FDA UDI | Class II | Active |
| HydroMark | 4010-01-08-T3 | FDA UDI | Class II | Active |
| Mammotome Revolve | MSCM1 | EUDAMEDFDA UDI | Class II | Active |
| neoprobe | NPRF18 | FDA UDI | Class I | Active |
| Mammotome MammoTest | B1021 | FDA UDI | Class II | Active |
| Mammotome | SCM23 | FDA UDI | Class II | Active |
| neoprobe | NPB14A | FDA UDI | Class I | Active |
| Mammotome revolve | MST1012 | EUDAMEDFDA UDI | Class II | Active |
| Mammotome | HHEX | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |