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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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FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
22 mm small
In Commercial Distribution

  • 00863008000102 ()

  • 22 mm
70-399-22

  • Contraceptive cervical cap, reusable
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
ETHICON INC.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
ASY-11748-2D
In Commercial Distribution

  • 15420045510388 ()
ASY-11748-2D

  • Stationary mammographic x-ray system, digital
No Description
Roche Diagnostics GmbH
07000979190
In Commercial Distribution

  • 00875197004885 ()
07000979190

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Diagnostics GmbH
06998836190
In Commercial Distribution

  • 00875197004717 ()
06998836190

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Stockert GmbH
19943
In Commercial Distribution

  • 04260166373080 ()
M004GEN100199430

  • Electrical-only medical device connection cable, reusable
INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-AB INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET
In Commercial Distribution

  • 07290015461924 ()
SET400168-AB

  • Therapeutic oncological/gynaecological ultrasound system
Low Height Head Frame Set NEURO-V2 (Inegra). multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-AA Low Height Head Frame Set NEURO-V2 (Inegra)
In Commercial Distribution

  • 07290015461917 ()
SET400168-AA

  • Therapeutic oncological/gynaecological ultrasound system
Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac Science(TM) electrodes part number 9131-001
AED BRANDS, LLC
AB 9131-001
In Commercial Distribution

  • 90865292000106 ()
  • 90865292000113 ()


  • Electrode conductive skin pad, single-use
Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and a paper insert on the electronic instructions for use.
SENSEONICS, INCORPORATED
FG-8402-01-201
In Commercial Distribution

  • 00817491024336 ()
FG-8402-01-201

  • Subcutaneous implantation kit, non-medicated
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