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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Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (1 Cuff) System
In Commercial Distribution

  • B970SV10 ()
SV1

  • Body-surface pressure mapping system
Includes 8 VersaTek Cuffs, 4 VersaTek 2-Port Hubs, 4 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101QL Map and 3 Equilibration Files, Help File and PDF of System Manual, 4 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 4 AC Power Cords, 4 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 4 VersaTek System
In Commercial Distribution

  • B970HRV40 ()
HRV4

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (2 Cuff) System
In Commercial Distribution

  • B970SV20 ()
SV2

  • Body-surface pressure mapping system
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, Waist Belt, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek System
In Commercial Distribution

  • B970FV20 ()
FV2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Wireless System
In Commercial Distribution

  • B970CVW20 ()
CVW2

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 1 VersaTek Wireless System
In Commercial Distribution

  • B970CVW10 ()
CVW1

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 4 ft. Cuff Cables, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.
Tekscan, Inc.
F-Scan VersaTek Wireless System
In Commercial Distribution

  • B970FVW20 ()
FVW2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual, Pre-configured wireless router, (2) 5330E Sensors, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Wireless/ Datalogger System
In Commercial Distribution

  • B970CVWD20 ()
CVWD2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Datalogger software features, (2) 5330E Sensors, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek Datalogger System
In Commercial Distribution

  • B970CVD20 ()
CVD2

  • Body-surface pressure mapping system
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