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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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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

IPS CaseDesigner® - 07332747199079

IPS CaseDesigner 2.5 for MAC
Nobel Biocare AB
2.5
In Commercial Distribution

  • 07332747199079 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747199062

IPS CaseDesigner 2.5 for Windows 64-bit
Nobel Biocare AB
2.5
In Commercial Distribution

  • 07332747199062 ()
300011

  • Dental treatment application software

Brevera Breast Biopsy System - 35420045507856

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

  • 35420045507856 ()
BREVSTXKITG

  • Mammographic stereotactic biopsy system

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

NeoNavia Biopsy System - 17350081940086

NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system

NeoNavia Biopsy System - 17350081940048

NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE - 15420045504295

ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE
In Commercial Distribution

  • 15420045504295 ()
ATEC SAPPHIRE

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE25 - 15420045504288

220V-50HZ ALL IN ONE BREAST BIOPSY SYSTEMS FOR BIOPS UNDER STEREOTATIC, ULTRASOND OR MRI GUIDNCE
Hologic, Inc.
ATEC SAPPHIRE25
In Commercial Distribution

  • 15420045504288 ()
ATEC SAPPHIRE25

  • Mammographic stereotactic biopsy system

ATEC Sapphire 200 - 15420045504110

200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC Sapphire 200
In Commercial Distribution

  • 15420045504110 ()
ATEC SAPPHIRE 200

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE 100 - 15420045504028

100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE 100
In Commercial Distribution

  • 15420045504028 ()
ATEC SAPPHIRE 100

  • Mammographic stereotactic biopsy system

Intra Oral Camera - 06971119542382

Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 03
In Commercial Distribution

  • 06971119542382 ()


  • Intraoral camera

Intra Oral Camera - 06971119540975

Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 02
In Commercial Distribution

  • 06971119540975 ()


  • Intraoral camera

Intra Oral Camera - 06971119540968

Intra Oral Camera
Guangdong JINME Medical Technology Co., Ltd.
ECO-CAMERA 01
In Commercial Distribution

  • 06971119540968 ()


  • Intraoral camera

ATEC PEARL - 15420045506855

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC OR ULTRASOUND GUIDANCE
Hologic, Inc.
ATEC PEARL
In Commercial Distribution

  • 15420045506855 ()
ATEC PEARL

  • Mammographic stereotactic biopsy system

ATEC EMERALD - 15420045506848

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER MRI
Hologic, Inc.
ATEC EMERALD
In Commercial Distribution

  • 15420045506848 ()
ATEC EMERALD

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506831

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-05205
In Commercial Distribution

  • 15420045506831 ()
  • 25420045506838 ()
ASY-05205

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506824

Affirm Lateral Arm Upright Biopsy Accessory Lateral Arm Stand
Hologic, Inc.
ASY-09644
In Commercial Distribution

  • 15420045506824 ()
  • 25420045506821 ()
ASY-09644

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506817

Affirm Lateral Arm Upright Biopsy Accessory
Hologic, Inc.
ASY-03723
In Commercial Distribution

  • 15420045506817 ()
  • 25420045506814 ()
ASY-03723

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506541

Affirm Prone Biopsy Complete Gantry
Hologic, Inc.
ASY-09175
In Commercial Distribution

  • 15420045506541 ()
ASY-09175

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506534

AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION
Hologic, Inc.
ASY-08832
In Commercial Distribution

  • 15420045506534 ()
ASY-08832

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506527

HV GENERATOR
Hologic, Inc.
ASY-06886
In Commercial Distribution

  • 15420045506527 ()
ASY-06886

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506510

AFFIRM PRONE BIOPSY SYSTEM, 3D
Hologic, Inc.
PBX-SYS-AFFIRM-3D
In Commercial Distribution

  • 15420045506510 ()
PBX-SYS-AFFIRM-3D

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506503

AFFIRM PRONE BIOPSY SYSTEM, 2D
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045506503 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506497

PADDLE, BIOPSY, LATERAL, 15 CM
Hologic, Inc.
ASY-08178
In Commercial Distribution

  • 15420045506497 ()
  • 25420045506494 ()
ASY-08178

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506480

PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM
Hologic, Inc.
ASY-08176
In Commercial Distribution

  • 15420045506480 ()
  • 25420045506487 ()
ASY-08176

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506473

PADDLE, BIOPSY, STANDARD, 5 CM X 5 CM
Hologic, Inc.
ASY-08175
In Commercial Distribution

  • 15420045506473 ()
  • 25420045506470 ()
ASY-08175

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506466

PADDLE, BIOPSY, AXILLA, 5 CM X 5 CM
Hologic, Inc.
ASY-08174
In Commercial Distribution

  • 15420045506466 ()
  • 25420045506463 ()
ASY-08174

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504738

AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

Affirm® - 15420045518087

Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004-CN
In Commercial Distribution

  • 15420045518087 ()
STLC-00004-CN

  • Mammographic stereotactic biopsy system

AFFIRM™ CONTRAST BIOPSY - 15420045512948

Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.
Hologic, Inc.
AFFIRM™ CONTRAST BIOPSY SOFTWARE
In Commercial Distribution

  • 15420045512948 ()
CMP-01771

  • Mammographic stereotactic biopsy system

AFFIRM™ SPECIMEN IMAGING - 15420045512931

No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045512863

Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREVDISP09
In Commercial Distribution

  • 15420045512863 ()
  • 15420045512870 ()
BREVDISP09

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045510845

No Description
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045510845 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system

Eviva - 15420045509962

PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA
Hologic, Inc.
EVIVA_CALIBRATE_13CM
In Commercial Distribution

  • 15420045509962 ()
  • 25420045509969 ()
EVIVA_CALIBRATE_13CM

  • Mammographic stereotactic biopsy system

Eviva - 15420045509948

PRODUCT, BUSHING, GE, EVIVA
Hologic, Inc.
EVIVA_BUSHING_GE
In Commercial Distribution

  • 15420045509948 ()
  • 25420045509945 ()
EVIVA_BUSHING_GE

  • Mammographic stereotactic biopsy system

Eviva - 15420045509931

No Description
Hologic, Inc.
EVIVA_STX_KIT_GIOTTO
In Commercial Distribution

  • 15420045509931 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509924

No Description
Hologic, Inc.
EVIVA_STX_KIT_INSPIR
In Commercial Distribution

  • 15420045509924 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509917

No Description
Hologic, Inc.
Eviva_STX_Kit_Opdima
In Commercial Distribution

  • 15420045509917 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509900

No Description
Hologic, Inc.
Eviva_STX_Kit_Affirm
In Commercial Distribution

  • 15420045509900 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509894

No Description
Hologic, Inc.
Eviva_STX_KIT_GEL-V
In Commercial Distribution

  • 15420045509894 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509887

No Description
Hologic, Inc.
Eviva_STX_KIT_GEVER
In Commercial Distribution

  • 15420045509887 ()


  • Mammographic stereotactic biopsy system
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