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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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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

Digital Spot Mammography System, DSM - 15420045506077

No Description
Hologic, Inc.
3-000-2247
Not in Commercial Distribution

  • 15420045506077 ()
3-000-2247

  • Mammographic stereotactic biopsy system

Multicare Platinum - 15420045505926

No Description
Hologic, Inc.
8-004-0017
Not in Commercial Distribution

  • 15420045505926 ()
8-004-0017

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045505858

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

  • 15420045505858 ()
STLC-00004

  • 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

Brevera Breast Biopsy System - 15420045515161

Reusable Driver
Hologic, Inc.
BREVDRV-02
In Commercial Distribution

  • 15420045515161 ()
BREVDRV-02

  • Mammographic stereotactic biopsy system

BIOPSY DIGIT - 08033837190219

Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
BIOPSY DIGIT AM
In Commercial Distribution

  • 18033837190216 ()
  • 08033837190219 ()

  • Height: 347 Millimeter
  • Depth: 303 Millimeter
  • Width: 350 Millimeter
9100-01

  • Mammographic stereotactic biopsy system

TRIOS 3 - 05902768365511

A battery operated moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS 3 battery cart
Not in Commercial Distribution

  • 05902768365511 ()


  • Dental milling system, CAD/CAM, chairside
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