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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 Class Implantable

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Cavitron® - D00381296021

Cavitron® Surface Mount Ultrasonic Scaler Model G98A Also contains: Steri-Mate® Handpiece with Swivel, 30K Focused Spray® Powerline™ Ultrasonic Insert (11 ft Surf)
Dentsply Professional
8129602
Not in Commercial Distribution

  • D00381296021 ()


  • Ultrasonic dental scaling/debridement system

Cavitron® - D00381296011

Cavitron® Surface Mount Ultrasonic Scaler Model G98A Also contains: Steri-Mate® Handpiece with Swivel, 30K Focused Spray® Powerline™ Ultrasonic Insert (6.5 ft Black)
Dentsply Professional
8129601
Not in Commercial Distribution

  • D00381296011 ()


  • Ultrasonic dental scaling/debridement system

Datex Ohmeda Compatible NIBP Hose, Adult, Mated Twist-Lock Connectors, 8 ft - B817AD22171800

No Description
CABLES AND SENSORS, LLC
AD-22-17/180
In Commercial Distribution

  • B817AD22171800 ()


  • Invasive blood pressure monitoring tubing set

Mobile Mat HR VersaTek - B970MMATHRRES0

Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built in VersaTek Cuffs, FootMat Software for Researchers CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat HR Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MMATHRRES0 ()
MMatHR-RES

  • Body-surface pressure mapping system

Mobile Mat HR VersaTek - B970MMATHRCLINICAL0

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

  • B970MMATHRCLINICAL0 ()
MMatHR-CLINICAL

  • Body-surface pressure mapping system

HR Mat VersaTek - B970HRV1RES0

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Researchers CD with 7101E Sensor 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 Researchers
In Commercial Distribution

  • B970HRV1RES0 ()
HRV1-RES

  • Body-surface pressure mapping system

F-Scan Lite VersaTek - B970FVL10

Includes 1 VersaTek Cuff, 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, 6 F-Scan 3000E Sensors, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Web-Based Training Session.
Tekscan, Inc.
F-Scan Lite VersaTek System
In Commercial Distribution

  • B970FVL10 ()
FVL1

  • Body-surface pressure mapping system

CONFORMat Versatek - B970CCV20

Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330E Sensors, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 VersaTek System
In Commercial Distribution

  • B970CCV20 ()
CCV2

  • Body-surface pressure mapping system

DUAL CHAMBER WARMING CABINET - B286W2630TDGMBEL1

Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storage Accuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Accuracy +/- 3 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature Lock Data Logger Electronic Locks Mobile Base Electrical: 120V, 12 Amp, 50/60 Hz .75kw/hr, 2557 btu/hr. UL/CUL listed. FDA Registered
M.A.C. MEDICAL INC.
W2630TD-G-MB-EL
In Commercial Distribution

  • B286W2630TDGMBEL1 ()
W2630TD-G-MB-EL

  • Blanket warming cabinet, dry-heat

DUAL CHAMBER WARMING CABINET - B286W2630TDG4B1

Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storage Accuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Accuracy +/- 3 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Temperature Lock Data Logger Upper chamber door lock Foot levelers Electrical: 120V, 12 Amp, 50/60 Hz .75kw/hr, 2557 btu/hr. UL/CUL listed. FDA Registered
M.A.C. MEDICAL INC.
W2630TD-G-4B
In Commercial Distribution

  • B286W2630TDG4B1 ()
W2630TD-G-4B

  • Blanket warming cabinet, dry-heat
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