Mammotome MR

FDA UDI

Class II (US FDA UDI)

by Devicor Medical Products, Inc.

Identity

Trade Name: Mammotome MR FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: Universal Targeting Set - Short FDA UDI
Model / Reference: MRU08S FDA UDI
Description: Universal Targeting Set - Short FDA UDI

Identifiers

Catalog Number: MRU08S FDA UDI
Primary DI / UDI-DI: 00841911101086 FDA UDI
510(k) Number: K042753 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 115 Millimeter FDA UDI
Needle Gauge — 8 Gauge FDA UDI

Category: Mammographic stereotactic biopsy system

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

Similar devices

Also classified as Mammographic stereotactic biopsy system.

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Brevera Breast Biopsy System — Hologic, Inc. · Class II
BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
Brevera Breast Biopsy System — Hologic, Inc. · Class II
Eviva — Hologic, Inc. · Class I
ENCOR® — SENORX, INC. · Class II
Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
ENCOR® — SENORX, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Devicor Medical Products, Inc.

Sources (1)

FDA UDI 7d9498b5-61b7-455d-a8d5-1d49d2cec33d 37 fields · synced Jun 8, 2026