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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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CONNECTOR 811191GR 110MM SS 4.5MM ROD S
MEDTRONIC SOFAMOR DANEK, INC.
811191GR
Not in Commercial Distribution

  • 00643169500525 ()

  • DIA= 4.5mm L=110mm


  • Bone-screw internal spinal fixation system, sterile
CONNECTOR 811203GR 40MM SS 5.5MM ROD S
MEDTRONIC SOFAMOR DANEK, INC.
811203GR
Not in Commercial Distribution

  • 00643169500457 ()

  • DIA=5.5mm L=40mm


  • Bone-screw internal spinal fixation system, sterile
CONNECTOR 811205GR 50MM SS 5.5MM ROD S
MEDTRONIC SOFAMOR DANEK, INC.
811205GR
Not in Commercial Distribution

  • 00643169500433 ()

  • DIA=5.5mm L=50mm


  • Bone-screw internal spinal fixation system, sterile
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101QL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (4) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 4 System
In Commercial Distribution

  • B970VH40 ()
VH4

  • Body-surface pressure mapping system
Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 3 System
In Commercial Distribution

  • B970VH30 ()
VH3

  • Body-surface pressure mapping system
Includes 8 Evolution Handles, (2) 4-Port Powered USB Hubs, BPMS Clinical Software CD with 5315O Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (8) 5315 Sensors with 1 Eight-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE8
In Commercial Distribution

  • B970BCE80 ()
BCE8

  • Body-surface pressure mapping system
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, BPMS Clinical Software CD with 5315QL Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 1 Four-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE4
In Commercial Distribution

  • B970BCE40 ()
BCE4

  • Body-surface pressure mapping system
A hand-held battery-powered electronic instrument designed to measure a patient's body temperature using infrared waves. The device has a infrared probe and an CD display. It is designed to take a temperature reading in approximately 1 second. This is a reusable device.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
KI-8271.CVS
In Commercial Distribution

  • 40050428360963 ()
  • 00050428360965 ()


  • Infrared patient thermometer, ear
HScribe Download Workstation - version 6 for Holter recording import. Includes current software CD, H3+ USB download cable, and H12+ CF card reader; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301557 ()
HSCRIBWS-6BA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Interface with remote RScribe database (requires RScribe database server)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263039 ()
RSCRIBE-6EC-XXDBC

  • Electrocardiograph, professional, multichannel
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