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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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SAS 55751006525 STER CCM 6.5 X 25
MEDTRONIC SOFAMOR DANEK, INC.
55751006525
In Commercial Distribution

  • 00763000211004 ()


  • Spinal bone screw, non-bioabsorbable
SAS 55751005525 STER CCM 5.5 X 25
MEDTRONIC SOFAMOR DANEK, INC.
55751005525
In Commercial Distribution

  • 00763000210991 ()


  • Spinal bone screw, non-bioabsorbable
SAS 55751004525 STER CCM 4.5 X 25
MEDTRONIC SOFAMOR DANEK, INC.
55751004525
In Commercial Distribution

  • 00763000210984 ()


  • Spinal bone screw, non-bioabsorbable
PK SET SCREW 6541104 STER BREAK OFF 4PK
MEDTRONIC SOFAMOR DANEK, INC.
6541104
In Commercial Distribution

  • 00763000211219 ()
  • 20763000211213 ()


  • Spinal bone screw, non-bioabsorbable
PK SET SCREW 6541102 STER BREAK OFF 2PK
MEDTRONIC SOFAMOR DANEK, INC.
6541102
In Commercial Distribution

  • 00763000211202 ()
  • 20763000211206 ()


  • Spinal bone screw, non-bioabsorbable
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
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970HRV10 ()
HRV1

  • Body-surface pressure mapping system
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
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); AHA 10 wire, 12-lead lead set with medi-clip ends; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319033 ()
RSCRIBE-6BC-XXACA

  • Electrocardiograph, professional, multichannel
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Brazil INMETRO labeling; Adult and pediatric interpretation; Software kit; No 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

  • 00732094262995 ()
RSCRIBE-6GC-XXCAA

  • Electrocardiograph, professional, multichannel
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