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Brevera Breast Biopsy System

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Brevera Breast Biopsy System FDA UDI
Generic Name
Mammographic stereotactic biopsy system FDA UDI
Device Name
Single-use, disposable needle for acquiring biopsy specimens. FDA UDI
Model / Reference
BREV09 FDA UDI
Description
Single-use, disposable needle for acquiring biopsy specimens. FDA UDI

Identifiers

Catalog Number
BREV09 FDA UDI
Primary DI / UDI-DI
15420045507777 FDA UDI
510(k) Number
K163052 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Brevera Breast Biopsy System by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI beb97b43-9f19-4c1a-be72-872125a828ce 37 fields · synced Jun 8, 2026