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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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System 83 Revolve - 00860010835241

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
Wassenburg Medical, Inc.
System 83 Revolve
In Commercial Distribution

  • 00860010835241 ()


  • Endoscope washer-disinfector (chemical)

Scope Assist Flushing Sink (SAFS) - 00860010835227

Device to flush endoscopes
Wassenburg Medical, Inc.
S8
In Commercial Distribution

  • 00860010835227 ()


  • Endoscope washer-disinfector (chemical)

Scope Assist Flushing Sink (SAFS) - 00860010835210

A device use to flush endoscopes.
Wassenburg Medical, Inc.
S6
In Commercial Distribution

  • 00860010835210 ()


  • Endoscope washer-disinfector (chemical)

ILLUMINIX - 00860010833261

Slitlamp instrument galileo ZS style microscope for eye examination
Illuminix Industries LLC
CLARCION MAX Z
In Commercial Distribution

  • 00860010833261 ()


  • Ophthalmic examination slit lamp

ILLUMINIX - 00860010833247

Slitlamp instrument galileo HS style microscope for eye examination
Illuminix Industries LLC
CLARICON MAX
In Commercial Distribution

  • 00860010833247 ()


  • Ophthalmic examination slit lamp

ILLUMINIX - 00860010833209

Slitlamp instrument galileo HS style microscope for eye examination
Illuminix Industries LLC
CLARICON
In Commercial Distribution

  • 00860010833209 ()


  • Ophthalmic examination slit lamp

Oivi Opthalmic Fundus Camera - 00860010826812

The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only.
Oivi AS
OFC100L
In Commercial Distribution

  • 00860010826812 ()


  • Ophthalmic fundus camera

TECHFIT - 00860010801697

Mandible And Maxilla Model - 2 Piece
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801697 ()
MAPMANI2P

  • Custom-made organ/bone anatomy model

TECHFIT - 00860010801680

Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860010801673

Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide
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