Mammotome elite

FDA UDI

Class II (US FDA UDI)

by Devicor Medical Products, Inc.

Identity

Trade Name: Mammotome elite FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: "Holster (tetherless vacuum-assisted biopsy system)" Direct Mark FDA UDI
Model / Reference: MEH1 FDA UDI
Description: "Holster (tetherless vacuum-assisted biopsy system)" Direct Mark FDA UDI

Identifiers

Catalog Number: DIRECT MARK FDA UDI
Primary DI / UDI-DI: 00841911101703 FDA UDI
510(k) Number: K153709 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mammographic stereotactic biopsy system

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

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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 8025295c-a042-43ef-b87e-5e51d90b59c0 37 fields · synced Jun 8, 2026