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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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CorPath 200 Control Console Drape - 00816280022096

No Description
Corindus, Inc.
160-00981
Not in Commercial Distribution

  • 00816280022096 ()
  • 00816280022089 ()
160-00981

  • Cardiac mapping system workstation

CorPath 200 POGO Pin Caps - 00816280022072

No Description
Corindus, Inc.
160-00876
Not in Commercial Distribution

  • 00816280022072 ()
  • 00816280022065 ()
160-00876

  • Cardiac mapping system workstation

CorPath 200 Cassette - 00816280022041

No Description
Corindus, Inc.
160-00173-NC
Not in Commercial Distribution

  • 00816280022041 ()
160-00173-NC

  • Cardiac mapping system workstation

Digital Denture - 00810002220128

Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin.
JOHN'S DENTAL LABORATORY INC
3014680794
Not in Commercial Distribution

  • 00810002220128 ()


  • CAD/CAM software
  • Dental milling system, CAD/CAM, laboratory

CORI - 00885556809655

CORI KNEE TENSIONER CARTRIDGE
Smith & Nephew, Inc.
ROB10101
In Commercial Distribution

  • 00885556809655 ()
ROB10101

  • Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter

Welch Allyn, Inc. - 00732094211023

ProBP 2400 Power Supply
WELCH ALLYN, INC.
901122
In Commercial Distribution

  • 00732094211023 ()
2400-PS

  • Automatic-inflation electronic sphygmomanometer, non-portable

Spacelabs - 10841522124570

UNIVERSAL CUFF COVER STANDARD SIZE - BOX OF 50
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522124570 ()
706-0182-00

  • Blood pressure ambulatory recorder

Beacon Care Package - Soft Tissue (17G) - 00850011006139

The Beacon transponder is an implantable wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The Beacon Care package consists of three Beacon transponders, each with a dedicated introducer needle. The Beacon transponders are implanted in or near the treatment target. The resonance signal is used to measure the location of the transponder, by the Calypso System. The BCP-Soft Tissue many only be used with the Calypso System v3.0 or higher.
VARIAN MEDICAL SYSTEMS, INC.
ASM0607-002
In Commercial Distribution

  • 00850011006139 ()

  • Needle Gauge: 17 Gauge


  • Radiation therapy invasive marker lesion localization system

Calypso Beacon Care Package-Lung - 00850011006122

No Description
VARIAN MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00850011006122 ()
ASM0341

  • Radiation therapy invasive marker lesion localization system

Beacon Care Package - Soft Tissue (17G) - 00850011006047

The Beacon transponder is an implantable wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The Beacon Care package consists of three Beacon transponders, each with a dedicated introducer needle. The Beacon transponders are implanted in or near the treatment target. The resonance signal is used to measure the location of the transponder, by the Calypso System. The BCP-Soft Tissue many only be used with the Calypso System v3.0 or higher.
VARIAN MEDICAL SYSTEMS, INC.
ASM0607-001
In Commercial Distribution

  • 00850011006047 ()

  • Needle Gauge: 17 Gauge
ASM0607-001

  • Radiation therapy invasive marker lesion localization system
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