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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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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
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left
Not in Commercial Distribution

  • 00816818021478 ()
ZBH-PSNCRCD39-L

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right
Not in Commercial Distribution

  • 00816818021423 ()
ZBH-PSNCRCD39-R

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left
Not in Commercial Distribution

  • 00816818021416 ()
ZBH-PSNCRCD39-L

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right
Not in Commercial Distribution

  • 00816818021485 ()
ZBH-PSNCRCD39-R

  • Arthroplasty force sensor
Includes 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9801 Sensors -or- (2) 9830 sensors.
Tekscan, Inc.
Prosthetic 1 (1 Handle) System
In Commercial Distribution

  • B970PE10 ()
PE1

  • Body-surface pressure mapping system
Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, SportsAT Software CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable
Tekscan, Inc.
MatScan VersaTek Platform with SportsAT Software
In Commercial Distribution

  • B970MV1SPORTS0 ()
MV1-SPORTS

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, I-Scan Software CD with 2 K-Scan Sensor maps, Sensor Carrying Case, System Carrying Case, and System Manual. 1 Day of Training (USA Only). Sensor selection: Choice of up to 5 sensors corresponding to the maps chosen above (value up to $1,000)
Tekscan, Inc.
K-Scan Joint Pressure Measurement System
In Commercial Distribution

  • B970KE10 ()
KE1

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, (1) 4-Port Powered USB Hub, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System
In Commercial Distribution

  • B970CCE20 ()
CCE2

  • Body-surface pressure mapping system
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