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Mammotome revolve

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MST0812

by Devicor Medical Products, Inc.

Identity

Trade Name
Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMED
Mammotome revolve FDA UDI
Generic Name
Side-notch biopsy gun handpiece/needle FDA UDI
Device Name
Probe EUDAMED
Stereotactic Probe - Slide Lock - CE FDA UDI
Model / Reference
MST0812 EUDAMEDFDA UDI
Description
Stereotactic Probe - Slide Lock - CE FDA UDI

Identifiers

Catalog Number
CA000399008 FDA UDI
Primary DI / UDI-DI
00841911102571 EUDAMEDFDA UDI
Basic UDI-DI
08419111AD02C000003322RG EUDAMED
510(k) Number
K152989 FDA UDI
FDA Product Code
KNW FDA UDI
EMDN Code
A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
GMDN Term
Side-notch biopsy gun handpiece/needle FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 8 Gauge FDA UDI

Mammotome revolve by Devicor Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K152989 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Devicor Medical Products, Inc.

Sources (2)

  • FDA UDI c87f84fa-a20f-4eb8-afbf-927de7ca3324 38 fields · synced Jul 31, 2026
  • EUDAMED 24a3553e-e764-475c-97c6-5ef7c770f32c 61 fields · synced Jul 31, 2026