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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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Pn Medical Inc
B-Recover
In Commercial Distribution

  • 00865202000117 ()


  • Tongue/lip exerciser
1.25cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN012
In Commercial Distribution

  • 00865179000073 ()
IQSP-PP-101

  • Synthetic bone graft
2.5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN010
In Commercial Distribution

  • 00865179000066 ()
IQSP-PP-102

  • Synthetic bone graft
5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN009
In Commercial Distribution

  • 00865179000059 ()
IQSP-PP-105

  • Synthetic bone graft
10cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN008
In Commercial Distribution

  • 00865179000042 ()
IQSP-PP-110

  • Synthetic bone graft
5x5cm Matrix
ISTO TECHNOLOGIES INC
IN007
In Commercial Distribution

  • 00865179000035 ()
IQSP-MX-125

  • Synthetic bone graft
5x10cm Matrix
ISTO TECHNOLOGIES INC
IN006
In Commercial Distribution

  • 00865179000028 ()
IQSP-MX-150

  • Synthetic bone graft
10cc Granules
ISTO TECHNOLOGIES INC
IN002
In Commercial Distribution

  • 00865179000011 ()
IQSP-GR-110

  • Synthetic bone graft
30cc Granules
ISTO TECHNOLOGIES INC
IN001
In Commercial Distribution

  • 00865179000004 ()
IQSP-GR-130

  • Synthetic bone graft
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
A34
In Commercial Distribution

  • 00865064000195 ()


  • Dressing-fixation skin adhesive tape, non-silicone
The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
VIVALNK, INC.
A13
In Commercial Distribution

  • 00865064000188 ()


  • Dressing-fixation skin adhesive tape, silicone
The wireless Enfasmart FeverSense 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.
VV220
In Commercial Distribution

  • 00865064000164 ()


  • Wireless patient thermometer, reusable
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV330
In Commercial Distribution

  • 00865064000157 ()


  • Electrocardiography telemetric monitoring system
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
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
The wireless Fever Scoutâ„¢ 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
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
Biliary Stone Removal Device
ENDO RX LLC
1
Not in Commercial Distribution

  • 00865014000305 ()
Model 1

  • ERCP catheter, balloon, non-electrical, stone-retrieval
LED light for the treatment of acne
PULSADERM LLC
PD9500
In Commercial Distribution

  • 00864918000336 ()


  • Red/blue light phototherapy unit
Blue LED Light for the treatment of mild to moderate acne
PULSADERM LLC
PD5000B
In Commercial Distribution

  • 00864918000329 ()


  • Red/blue light phototherapy unit
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