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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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Fever Scout Adhesive Refill - 00865064000133

The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
VV200A
In Commercial Distribution

  • 00865064000133 ()


  • Dressing-fixation skin adhesive tape, silicone

Enfasmart feversense Adhesive Refill Pack - 00865064000126

The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
VV220A
In Commercial Distribution

  • 00865064000126 ()


  • Dressing-fixation skin adhesive tape, silicone

Fever Scout Continuous monitoring thermometer - 00865064000119

The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable

Rhino S - 00865014000312

Short Wire Compatible Biliary Catheter Device
ENDO RX LLC
1
Not in Commercial Distribution

  • 00865014000312 ()
600001-Rhino-SW

  • ERCP catheter, balloon, non-electrical, stone-retrieval

Rhino SRD - 00865014000305

Biliary Stone Removal Device
ENDO RX LLC
1
Not in Commercial Distribution

  • 00865014000305 ()
Model 1

  • ERCP catheter, balloon, non-electrical, stone-retrieval

A.C.E Red and Blue - 00864918000336

LED light for the treatment of acne
PULSADERM LLC
PD9500
In Commercial Distribution

  • 00864918000336 ()


  • Red/blue light phototherapy unit

Blue LED Acne Clearing Light - 00864918000329

Blue LED Light for the treatment of mild to moderate acne
PULSADERM LLC
PD5000B
In Commercial Distribution

  • 00864918000329 ()


  • Red/blue light phototherapy unit

Pulsaderm RED LED Skin Renewal - 00864918000312

Red LED Light for Wrinkles
PULSADERM LLC
PD5000R
In Commercial Distribution

  • 00864918000312 ()


  • Red/blue light phototherapy unit

A.C.E Blue - 00864918000305

Blue Light for the treatment of acne
PULSADERM LLC
PD9505
In Commercial Distribution

  • 00864918000305 ()


  • Red/blue light phototherapy unit

Radlink GPS Trauma - 00864908000162

The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS and its Surgeon’s Checklist™ software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS consists of a computer system that uses one ultra-wide monitor.
RADLINK, INC.
GPS Trauma
In Commercial Distribution

  • 00864908000162 ()


  • Computed radiography digital imaging scanner
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