ENCOR ENSPIRE® E4115

GUDID 00801741086113

ENCOR ENSPIRE® Breast Biopsy System

SENORX, INC.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system
Primary Device ID00801741086113
NIH Device Record Keyd4eba16f-8f46-45c6-9b6a-28804cd99ffa
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCOR ENSPIRE®
Version Model NumberE4115
Catalog NumberE4115
Company DUNS043674543
Company NameSENORX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)321-4254
Emailmedical.services@crbard.com
Phone+1(800)321-4254
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741086113 [Primary]

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2016-09-20

On-Brand Devices [ENCOR ENSPIRE®]

00801741086113ENCOR ENSPIRE® Breast Biopsy System
10801741086103ENCOR ENSPIRE® Breast Biopsy System Vacuum Tubing Cassette
10801741086097ENCOR ENSPIRE® Breast Biopsy System Vacuum and Rinse Tubing Cassette
00801741085956ENCOR ENSPIRE® Breast Biopsy System Driver Holder

Trademark Results [ENCOR ENSPIRE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENCOR ENSPIRE
ENCOR ENSPIRE
85231385 4168792 Live/Registered
C. R. Bard, Inc.
2011-02-01

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