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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No Description
VOLK OPTICAL INC.
VVITHAN-LG
In Commercial Distribution

  • 00811608016467 ()


  • Vitrectomy contact lens positioning handle
No Description
United Exchange Corp.
1
In Commercial Distribution

  • 00780707000007 ()


  • Multi-purpose soft contact lens solution
No Description
SEPTODONT, INC
01C2010
In Commercial Distribution

  • 00303620000567 ()

  • Weight: 4 Gram


  • Multi-purpose soft contact lens solution
SYSTANE Contacts Lubricant Eye Drops 12ml
Alcon Laboratories, Inc.
SYSTANE 12ml
In Commercial Distribution

  • 00300650190930 ()
  • 20300650190934 ()


  • Contact lens wetting solution
  • Eye lubricant
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
EARLENS CORPORATION
PLEL1LR
Not in Commercial Distribution

  • 08500130070086 ()
  • 08500130070178 ()
PLEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
No Description
EARLENS CORPORATION
ET01R
In Commercial Distribution

  • 00850013007554 ()
ET01R

  • Tympanic membrane contact hearing aid ear tip transmitter
No Description
EARLENS CORPORATION
ET01L
In Commercial Distribution

  • 00850013007547 ()
ET01L

  • Tympanic membrane contact hearing aid ear tip transmitter
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution

  • 00850013007295 ()
ELF002

  • Audiometric/hearing device software
Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, Ear Tip comes in L - Left, R - Right
EARLENS CORPORATION
PET01X
Not in Commercial Distribution

  • 00850013007233 ()
PET01X

  • Tympanic membrane contact hearing aid sound processor
  • Tympanic membrane contact hearing aid ear tip transmitter
Inductive Ear Tip w/ left & right packaged
EARLENS CORPORATION
ET01LR
In Commercial Distribution

  • 00850013007226 ()
  • 00850013007318 ()
ET01LR

  • Tympanic membrane contact hearing aid ear tip transmitter
Inductive Ear Tip comes in L - Left, R - Right
EARLENS CORPORATION
ET01X
Not in Commercial Distribution

  • 00850013007219 ()
ET01X

  • Tympanic membrane contact hearing aid ear tip transmitter
Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right
EARLENS CORPORATION
PLEL1X
Not in Commercial Distribution

  • 00850013007073 ()
PLEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Light Tip w/ left & right packaged
EARLENS CORPORATION
LTEL1LR
Not in Commercial Distribution

  • 00850013007066 ()
  • 00850013007165 ()
LTEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
Light Tip comes in L - Left, R - Right
EARLENS CORPORATION
LTEL1X
Not in Commercial Distribution

  • 00850013007059 ()
LTEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
No Description
EARLENS CORPORATION
CHEL101
In Commercial Distribution

  • 00850013007035 ()
CHEL101

  • Noninvasive device battery charger
The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-7000
In Commercial Distribution

  • 00860447001714 ()


  • Thermographic camera
The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-5000
Not in Commercial Distribution

  • 00860447001707 ()


  • Thermographic camera
No Description
ALIMED, INC.
710806
In Commercial Distribution

  • 00733657230710 ()
2970008673

  • Vulnerable patient home alert system
Trigno System Component
DELSYS, INC.
SP-W01B
In Commercial Distribution

  • 00851679007094 ()


  • Biofeedback system
Installation Kit
ST. JUDE MEDICAL, INC.
Module
In Commercial Distribution

  • 05415067027733 ()
H702500-HW

  • Electrical-only medical device connection cable, reusable
No Description
Heine Optotechnik GmbH & Co. KG
SMALL
In Commercial Distribution

  • 04053755197118 ()
K-000.34.206

  • Dermatoscope, optical
No Description
Heine Optotechnik GmbH & Co. KG
STANDARD
In Commercial Distribution

  • 04053755197101 ()
K-000.34.220

  • Dermatoscope, optical
No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITHOUT SCALE
In Commercial Distribution

  • 04053755181377 ()
K-000.34.217

  • Dermatoscope, optical
No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755181315 ()
K-000.34.216

  • Dermatoscope, optical
No Description
Heine Optotechnik GmbH & Co. KG
SMALL
In Commercial Distribution

  • 04053755135486 ()
K-000.34.205

  • Dermatoscope, optical
No Description
Carl Zeiss Meditec AG
304111-0180-000
In Commercial Distribution

  • 04049539103673 ()
  • 04049539103406 ()


  • Medical equipment/instrument drape, reusable
DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW30-12
Not in Commercial Distribution

34-WINDOW30-12

  • General internal orthopaedic fixation system implantation kit
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL36-10-8
Not in Commercial Distribution

34-TRL36-10-8

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL36-10-4
Not in Commercial Distribution

34-TRL36-10-4

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL30-20-0
Not in Commercial Distribution

34-TRL30-20-0

  • Surgical implant template, reusable
TRIAL SPACER
Pioneer Surgical Technology, Inc.
34-TRL30-18-0
Not in Commercial Distribution

34-TRL30-18-0

  • Surgical implant template, reusable
DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW40-14
Not in Commercial Distribution

34-WINDOW40-14

  • General internal orthopaedic fixation system implantation kit
DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW40-12
Not in Commercial Distribution

34-WINDOW40-12

  • General internal orthopaedic fixation system implantation kit
DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW36-20
Not in Commercial Distribution

34-WINDOW36-20

  • General internal orthopaedic fixation system implantation kit
DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW36-18
Not in Commercial Distribution

34-WINDOW36-18

  • General internal orthopaedic fixation system implantation kit
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