Encor®

FDA UDI

Class II (US FDA UDI)

by Senorx, Inc.

Identity

Trade Name: ENCOR® FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: ENCOR® Breast Biopsy System Vacuum Package FDA UDI
Model / Reference: SCVACPAK3000 FDA UDI
Description: ENCOR® Breast Biopsy System Vacuum Package FDA UDI

Identifiers

Catalog Number: SCVACPAK3000 FDA UDI
Primary DI / UDI-DI: 00801741086731 FDA UDI
FDA Product Code: GEI FDA UDI
KNW FDA UDI
GMDN Term: Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

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

Category: Mammographic stereotactic biopsy system

Encor® by Senorx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mammographic stereotactic biopsy system.

ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
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
Mammotome — Devicor Medical Products, Inc. · Class II
Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
EleVation™ — Bard Peripheral Vascular · Class II

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: Senorx, Inc.

Sources (1)

FDA UDI eddab316-cfb6-4d8f-b35d-5712693c3ef2 35 fields · synced May 30, 2026