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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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NIRA PRO - 00850020752119

The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece

NA - 05415067029072

DRG EPG Kit Accessories
ADVANCED NEUROMODULATION SYSTEMS, INC.
7885
In Commercial Distribution

  • 05415067029072 ()
7885

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

ET20S™ - 05415067022325

Radiofrequency Generator
ST. JUDE MEDICAL, INC.
NT7209975
In Commercial Distribution

  • 05415067022325 ()
NT7209975

  • Percutaneous radio-frequency ablation system generator

Beurer - 00850003500676

SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable (with cuff 22-42 cm).
BEURER NORTH AMERICA, L.P.
BM50
In Commercial Distribution

  • 00850003500676 ()
668.80

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Vitalcontrol - 00850003500485

SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, portable (with cuff 22-42 cm).
BEURER NORTH AMERICA, L.P.
SBM52
In Commercial Distribution

  • 10850003500482 ()
  • 00850003500485 ()
668.10, 666.16

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Wi-Box™ - 05414734054164

Cable
ST. JUDE MEDICAL, INC.
PSU Kit
In Commercial Distribution

  • 05414734054164 ()
C12785

  • Electrical mains power cable

Wi-Box™ - 05414734054140

Signal Transceiver
ST. JUDE MEDICAL, INC.
AO Transmitter
In Commercial Distribution

  • 05414734054140 ()
C12783

  • Medical networking interface unit

Beurer - 00850003500041

Infrared Lamp
BEURER NORTH AMERICA, L.P.
IL51
In Commercial Distribution

  • 10850003500048 ()
  • 00850003500041 ()
Art.- No. 619.73

  • Musculoskeletal infrared phototherapy unit, non-wearable

Eon Mini™ - 05414734405324

Charger Accessory
ADVANCED NEUROMODULATION SYSTEMS, INC.
3720
In Commercial Distribution

  • 05414734405324 ()
3720

  • Noninvasive device battery charger

Eon Mini™ - 05414734405300

Eon Mini LE Charging System
ADVANCED NEUROMODULATION SYSTEMS, INC.
3722
In Commercial Distribution

  • 05414734405300 ()
3722

  • Noninvasive device battery charger
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