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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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SCREW 55850016075 5.5 VOYAGER MAS 6.0X75
MEDTRONIC SOFAMOR DANEK, INC.
55850016075
Not in Commercial Distribution

  • 00643169784246 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
SCREW 55850016070 5.5 VOYAGER MAS 6.0X70
MEDTRONIC SOFAMOR DANEK, INC.
55850016070
Not in Commercial Distribution

  • 00643169784239 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
SCREW 55850016065 5.5 VOYAGER MAS 6.0X65
MEDTRONIC SOFAMOR DANEK, INC.
55850016065
Not in Commercial Distribution

  • 00643169784222 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
SCREW 55850016060 5.5 VOYAGER MAS 6.0X60
MEDTRONIC SOFAMOR DANEK, INC.
55850016060
Not in Commercial Distribution

  • 00643169784215 ()

  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat Map, Help File and PDF of System Manual, (1)5330E Sensor, 10 ft. USB Cable, 25 ft. Cuff Cable, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 VersaTek System
In Commercial Distribution

  • B970CCV10 ()
CCV1

  • Body-surface pressure mapping system
Airwave Oscillometry System (US version) compatible with ClearFlo PFT filter including power supply, ethernet cable, user manual, and packaged with accessories: tremoFlo unit (DI 07540261013362), test load (DI 07540261009860), CD containing US Software and digital User Manual (DI 07540261016400). System used to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101524
In Commercial Distribution

  • 07540261015243 ()


  • Pulmonary function analysis system, adult
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; International power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263152 ()
RSCRIBE-6AC-DXCBB

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; Suction electrodes (6) and clamps (4); AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094325355 ()
RSCRIBE-6AC-AXCAA

  • Electrocardiograph, professional, multichannel
Includes 6 VersaTek Cuffs, 3 VersaTek 2-Port Hubs, 3 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101TL Map and 3 Equilibration Files, Help File and PDF of System Manual, 3 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 3 VersaTek System
In Commercial Distribution

  • B970HRV30 ()
HRV3

  • Body-surface pressure mapping system
Includes 4 VersaTek Cuffs, 2 VersaTek 2-Port Hubs, 2 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101D Map with 3 Equilibration Files, Help File and PDF of System Manual, 2 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 2 VersaTek System
In Commercial Distribution

  • B970HRV20 ()
HRV2

  • Body-surface pressure mapping system
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