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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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Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7217
In Commercial Distribution

  • 07331791010033 ()

  • Length: 6 Millimeter
7217

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7218
In Commercial Distribution

  • 07331791010026 ()

  • Length: 8 Millimeter
7218

  • Tracheoesophageal speech valve, indwelling
An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.
Zoll Circulation, Inc.
na
In Commercial Distribution

  • 00849111075428 ()

  • Catheter Gauge: 14 French
8700-000828-01

  • Intravascular core temperature regulation system catheter
No Description
FIRST AID BANDAGE CO INC
34116110
In Commercial Distribution

  • 00634303020191 ()
  • 30634303020192 ()

  • Length: 2 Inch
  • Length: 50.8 Millimeter
34116110

  • Bandage clip
Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure.
Leloi AB
8946
In Commercial Distribution

  • 07350075028946 ()


  • Penile ring
Single Use, Sterile Distal End Cap with Elevator OE-A65
HOYA CORPORATION
OE-A65
In Commercial Distribution

  • 04961333246236 ()
  • 14961333246233 ()


  • Endoscope patient protection cap, single-use
Single Use, Sterile Distal End Cap with Elevator OE-A63
HOYA CORPORATION
OE-A63
In Commercial Distribution

  • 04961333232994 ()
  • 14961333232991 ()


  • Endoscope patient protection cap, single-use
No Description
NOVATECH
109001T
In Commercial Distribution

  • 14063108104783 ()
109001T

  • Endoscopic spray catheter, single-use
No Description
DERMARITE INDUSTRIES LLC
45330
In Commercial Distribution

  • 00714196453303 ()
  • 01714196453302 ()


  • Tracheostomy tube dressing
No Description
DERMARITE INDUSTRIES LLC
45330
In Commercial Distribution

  • 00714196391902 ()


  • Tracheostomy tube dressing
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