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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Brevera Breast Biopsy System - 35420045507832

Kit used with a stereotactic guidance system compatible with Brevera(R) .
Hologic, Inc.
BREVSTXKITM
In Commercial Distribution

  • 35420045507832 ()
BREVSTXKITM

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 35420045507801

Kit used with a stereotactic guidance system compatible with Brevera(R).
Hologic, Inc.
BREVSTXKIT
In Commercial Distribution

  • 35420045507801 ()
BREVSTXKIT

  • Mammographic stereotactic biopsy system

Kaye Products - FT-2 - 00810117142735

Lock-In Place Frazier Table for S2A Bench
Kaye Products, Inc.
FT-2
Not in Commercial Distribution

  • 00810117142735 ()


  • Ergonomic workdesk, manual

Kaye Products - FT-1 - 00810117142728

Lock-In Place Frazier Table for S1A Bench
Kaye Products, Inc.
FT-1
Not in Commercial Distribution

  • 00810117142728 ()


  • Ergonomic workdesk, manual

Kaye Products - TT2 - 00810117142711

Large Tilting Table
Kaye Products, Inc.
TT2
Not in Commercial Distribution

  • 00810117142711 ()


  • Ergonomic workdesk, manual

Kaye Products - TT1 - 00810117142704

Small Tilting Table
Kaye Products, Inc.
TT1
Not in Commercial Distribution

  • 00810117142704 ()


  • Ergonomic workdesk, manual

NONE - B006EMGVIEW0

No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software

EleVation™ - 00801741182471

EleVation™ Breast Biopsy System Driver Loaner
Bard Peripheral Vascular, Inc.
EVLOANER
In Commercial Distribution

  • 00801741182471 ()
EVLOANER

  • Mammographic stereotactic biopsy system

EleVation™ - 00801741182464

EleVation™ Breast Biopsy System Driver Refurbished
Bard Peripheral Vascular, Inc.
EVREFURB
In Commercial Distribution

  • 00801741182464 ()
EVREFURB

  • Mammographic stereotactic biopsy system

EleVation™ - 00801741182365

EleVation™ Breast Biopsy System Driver
Bard Peripheral Vascular, Inc.
EVDRIVER
In Commercial Distribution

  • 00801741182365 ()
EVDRIVER

  • Mammographic stereotactic biopsy system

Blue Sky Bio, LLC. - 00810060226063

Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software

IPS CaseDesigner® - 07332747185836

IPS CaseDesigner 2.3 Mac
Nobel Biocare AB
2.3
In Commercial Distribution

  • 07332747185836 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747185829

IPS CaseDesigner 2.3 Win 64-bit
Nobel Biocare AB
2.3
In Commercial Distribution

  • 07332747185829 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747181944

DTX Studio Implant 3.6 for Mac
Nobel Biocare AB
3.6
In Commercial Distribution

  • 07332747181944 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747181937

DTX Studio Implant 3.6 for Windows 64-bit
Nobel Biocare AB
3.6
In Commercial Distribution

  • 07332747181937 ()
300843

  • Dental treatment application software

IPS CaseDesigner® - 07332747181920

IPS CaseDesigner 2.2 Mac
Nobel Biocare AB
2.2
In Commercial Distribution

  • 07332747181920 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747181913

IPS CaseDesigner 2.2 Win 64-bit
Nobel Biocare AB
2.2
In Commercial Distribution

  • 07332747181913 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747178258

IPS CaseDesigner 2.1 Mac
Nobel Biocare AB
2.1
Not in Commercial Distribution

  • 07332747178258 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747178241

IPS CaseDesigner 2.1 Win 64-bit
Nobel Biocare AB
2.1
Not in Commercial Distribution

  • 07332747178241 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747172829

DTX Studio Implant 3.5 for Mac
Nobel Biocare AB
3.5
In Commercial Distribution

  • 07332747172829 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747172805

DTX Studio Implant 3.5 for Windows 64-bit
Nobel Biocare AB
3.5
In Commercial Distribution

  • 07332747172805 ()
300843

  • Dental treatment application software

IPS CaseDesigner® - 07332747172065

IPS CaseDesigner 2.0 Mac
Nobel Biocare AB
2.0
Not in Commercial Distribution

  • 07332747172065 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747172058

IPS CaseDesigner 2.0 Win 64-bit
Nobel Biocare AB
2.0
Not in Commercial Distribution

  • 07332747172058 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747166125

DTX Studio Implant 3.4 for Mac
Nobel Biocare AB
3.4
In Commercial Distribution

  • 07332747166125 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747166101

DTX Studio Implant 3.4 for Win 64-bit
Nobel Biocare AB
3.4
In Commercial Distribution

  • 07332747166101 ()
300843

  • Dental treatment application software

NobelClinician® - 07332747128970

NobelClinician 3.2 for MAC
Nobel Biocare AB
3.2
Not in Commercial Distribution

  • 07332747128970 ()
101560

  • Dental treatment application software

NobelClinician® - 07332747128963

NobelClinician 3.2 for Windows 64-bit
Nobel Biocare AB
3.2
Not in Commercial Distribution

  • 07332747128963 ()
101560

  • Dental treatment application software

IPS CaseDesigner™ - 07332747126976

IPS CaseDesigner 1.3 for MAC
Nobel Biocare AB
1.3
Not in Commercial Distribution

  • 07332747126976 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747126969

IPS CaseDesigner 1.3 for Windows 64-bit
Nobel Biocare AB
1.3
Not in Commercial Distribution

  • 07332747126969 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747125009

IPS CaseDesigner 1.2 for MAC
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747125009 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747124996

IPS CaseDesigner 1.2 for Windows 64-bit
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747124996 ()
300011

  • Dental treatment application software

MedRx - 00810044583045

No Description
MEDRX, INC.
MedRx AWRC
In Commercial Distribution

  • 00810044583045 ()


  • Tone audiometer

MedRx - 00810044580112

No Description
MEDRX, INC.
Avant AIR+
In Commercial Distribution

  • 00810044580112 ()


  • Tone audiometer

MedRx - 00810044580082

No Description
MEDRX, INC.
MedRx Tinnometer
Not in Commercial Distribution

  • 00810044580082 ()


  • Tone audiometer

MedRx - 00810044580044

No Description
MEDRX, INC.
Avant Stealth Audiometer
In Commercial Distribution

  • 00810044580044 ()


  • Tone audiometer

MedRx - 00810044580013

No Description
MEDRX, INC.
Avant ARC
In Commercial Distribution

  • 00810044580013 ()


  • Tone audiometer

MedRx - 00810044580006

No Description
MEDRX, INC.
Avant A2D+
In Commercial Distribution

  • 00810044580006 ()


  • Tone audiometer

MedRx - 00810044582963

No Description
MEDRX, INC.
MedRx Kiosk
In Commercial Distribution

  • 00810044582963 ()


  • Tone audiometer

ENCOR® - 00801741086755

ENCOR® Breast Biopsy System Vacuum System
SENORX, INC.
VS3000
Not in Commercial Distribution

  • 00801741086755 ()
VS3000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086731

ENCOR® Breast Biopsy System Vacuum Package
SENORX, INC.
SCVACPAK3000
In Commercial Distribution

  • 00801741086731 ()
SCVACPAK3000

  • Mammographic stereotactic biopsy system

ENCOR ULTRA® - 00801741086724

ENCOR ULTRA® Breast Biopsy System Vacuum Tubing
SENORX, INC.
SCTUB4000
In Commercial Distribution

  • 10801741086721 ()
  • 00801741086724 ()
SCTUB4000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086717

ENCOR® Breast Biopsy System Vacuum Tubing Set
SENORX, INC.
SCTUB3000
In Commercial Distribution

  • 10801741086714 ()
  • 00801741086717 ()
SCTUB3000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086557

ENCOR® Breast Biopsy System Footswitch For use with EnCor® System
SENORX, INC.
FSENCOR01
In Commercial Distribution

  • 00801741086557 ()
FSENCOR01

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086540

ENCOR® Breast Biopsy System MRI Footswitch
SENORX, INC.
FSENCORMR
In Commercial Distribution

  • 00801741086540 ()
FSENCORMR

  • Mammographic stereotactic biopsy system

EnCor - 00801741086496

EnCor Breast Biopsy System Needle Guide (Fischer) For use with Fischer Stereotactic Imaging Tables
SENORX, INC.
ENCFNGUIDE01
In Commercial Distribution

  • 00801741086496 ()
ENCFNGUIDE01

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086458

ENCOR® Breast Biopsy System Fire Forward Accessory
SENORX, INC.
ENCFF02
In Commercial Distribution

  • 00801741086458 ()
ENCFF02

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086441

ENCOR® Breast Biopsy System Fire Forward Adapter Accessory
SENORX, INC.
ENCFF01
Not in Commercial Distribution

  • 00801741086441 ()
ENCFF01

  • Mammographic stereotactic biopsy system

ENCOR ULTRA® - 00801741086137

ENCOR ULTRA® Breast Biopsy System
SENORX, INC.
E5115
In Commercial Distribution

  • 00801741086137 ()
E5115

  • Mammographic stereotactic biopsy system

ENCOR ENSPIRE® - 00801741086113

ENCOR ENSPIRE® Breast Biopsy System
SENORX, INC.
E4115
In Commercial Distribution

  • 00801741086113 ()
E4115

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086083

ENCOR® Breast Biopsy System MRI Driver
SENORX, INC.
DRENCORMR
In Commercial Distribution

  • 00801741086083 ()
DRENCORMR

  • Mammographic stereotactic biopsy system
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