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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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Aria E-valve - 00850013242054

Aria E-valve auto expulsion suction valve for test sockets
CYPRESS ADAPTIVE, LLC
CA200-AE
In Commercial Distribution

  • 00850013242054 ()
CA200-AE

  • External lower-limb prosthesis suspensory component, non-powered

Aria valve plus (metric) - 00850013242047

Aria valve (metric) auto expulsion suction valve for prosthetic sockets.
CYPRESS ADAPTIVE, LLC
CA200AVPM
In Commercial Distribution

  • 00850013242047 ()
CA200AVPM

  • External lower-limb prosthesis suspensory component, non-powered

Aria Valve Plus (US) - 00850013242030

Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
CYPRESS ADAPTIVE, LLC
CA200-AVP
In Commercial Distribution

  • 00850013242030 ()
CA200-AVP

  • External lower-limb prosthesis suspensory component, non-powered

Aria valve (metric) - 00850013242023

Aria valve (metric threads) auto expulsion suction valve for prosthetic sockets.
CYPRESS ADAPTIVE, LLC
CA200-AVM
In Commercial Distribution

  • 00850013242023 ()
CA200-AVM

  • External lower-limb prosthesis suspensory component, non-powered

Aria Mini Valve - 00850013242016

Valve for installation into limb prosthesis with a small diameter and low profile.
CYPRESS ADAPTIVE, LLC
CA100-MV
Not in Commercial Distribution

  • 00850013242016 ()
CA100-MV

  • External lower-limb prosthesis suspensory component, non-powered

Aria Valve (US) - 00850013242009

Auto Expulsion suction valve (US threads) for prosthetic sockets
CYPRESS ADAPTIVE, LLC
CA200-AV
In Commercial Distribution

  • 00850013242009 ()
CA200-AV

  • External lower-limb prosthesis suspensory component, non-powered

RADPAD - 00850013127108

Peripheral Shield-Blue
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
5110A-B
In Commercial Distribution

  • 10850013127105 ()
  • 00850013127108 ()


  • Patient radiation shielding pad/drape, single-use

VibrantVue - 00850013056064

Hand Cleanser 8oz
Dry Eye Innovations, LLC
2020.03
In Commercial Distribution

  • 00850013056064 ()

  • Total Volume: 8 Fluid Ounce
1HC2

  • Antimicrobial wound irrigation solution

VibrantVue - 00850013056057

Hand Cleanser 2oz
Dry Eye Innovations, LLC
2020.03
In Commercial Distribution

  • 00850013056057 ()

  • Total Volume: 2 Fluid Ounce
1HC2

  • Antimicrobial wound irrigation solution

SureLase - 00850013050215

Clinicon "SureLase" 30 Watt Laser System, 3-Year Warranty
Clinicon Corporation
4060
In Commercial Distribution

  • 00850013050215 ()


  • General/multiple surgical diode/carbon dioxide laser system

Luxar - 00850013050208

Luxar "NovaPulse" 30 Watt Laser System, refurbished, 2-Year Warranty
Clinicon Corporation
4151
In Commercial Distribution

  • 00850013050208 ()


  • General/multiple surgical diode/carbon dioxide laser system

SureScan - 00850013050192

SureScan, Fractional Laser Scanner
Clinicon Corporation
3566
In Commercial Distribution

  • 00850013050192 ()


  • General/multiple surgical diode/carbon dioxide laser system

SureGuide - 00850013050185

SureGuide, 2.75m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4143
In Commercial Distribution

  • 00850013050185 ()


  • General/multiple surgical laser system beam guide, single-use

SureGuide - 00850013050178

SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
Clinicon Corporation
3156
In Commercial Distribution

  • 00850013050178 ()


  • General/multiple surgical laser system beam guide, single-use

SureGuide - 00850013050161

SureGuide, 2.00m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4140
In Commercial Distribution

  • 00850013050161 ()


  • General/multiple surgical laser system beam guide, single-use

SureGuide - 00850013050154

SureGuide, 2.00m Fiber Cable Assembly, SMA Connector with Interlock Wire
Clinicon Corporation
4034
In Commercial Distribution

  • 00850013050154 ()


  • General/multiple surgical laser system beam guide, single-use

SureBlade - 00850013050147

SureBlade 8mm, BiFacet, single edged, (No.11)
Clinicon Corporation
2986
In Commercial Distribution

  • 00850013050147 ()


  • General/multiple surgical diode/carbon dioxide laser system

SureBlade - 00850013050130

SureBlade 6mm, Lance, double edged, (No. 13)
Clinicon Corporation
2572
In Commercial Distribution

  • 00850013050130 ()


  • General/multiple surgical diode/carbon dioxide laser system

SureTip - 00850013050123

SureTip, GEN, 10mm, straight tip
Clinicon Corporation
3728
In Commercial Distribution

  • 00850013050123 ()


  • General/multiple surgical laser system beam guide, single-use

SureTouch - 00850013050116

SureTouch, 1.5mm Universal HandPiece (UHP)
Clinicon Corporation
4012
In Commercial Distribution

  • 00850013050116 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050093

SureProbe ENT, Oto, 70mm Single Curve Assembly
Clinicon Corporation
4011
In Commercial Distribution

  • 00850013050093 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050086

SureProbe ENT, Larynx, 240mm Malleable Dissecting Tip Assembly
Clinicon Corporation
4149
In Commercial Distribution

  • 00850013050086 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050079

SureProbe ENT, Pedriatric, Larynx, 140mm Malleable Dissecting Tip Assembly
Clinicon Corporation
4159
In Commercial Distribution

  • 00850013050079 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050062

SureProbe ENT, 80mm, Oral, Single Curved Dissecting Tip Assembly
Clinicon Corporation
4004
In Commercial Distribution

  • 00850013050062 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050055

SureProbe ENT, 80mm, Oral, Straight Dissecting Tip Assembly
Clinicon Corporation
4008
In Commercial Distribution

  • 00850013050055 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050048

SureProbe, ENT, 50mm, Nasal, Single Curved Dissecting Tip Assembly
Clinicon Corporation
4003
In Commercial Distribution

  • 00850013050048 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050031

SureProbe, ENT, 50mm, Nasal Straight Dissecting Tip Assembly
Clinicon Corporation
4007
In Commercial Distribution

  • 00850013050031 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050024

SureProbe, Neuro, 80mm Straight Dissecting Tip Assembly Copy
Clinicon Corporation
4002
In Commercial Distribution

  • 00850013050024 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050017

SureProbe, Neuro, 50mm Straight Dissecting Tip Assembly
Clinicon Corporation
4001
In Commercial Distribution

  • 00850013050017 ()


  • General/multiple surgical laser system beam guide, single-use

SureProbe - 00850013050000

SureProbe, Neuro, 40mm Straight Dissecting Tip Assembly
Clinicon Corporation
4000
In Commercial Distribution

  • 00850013050000 ()


  • General/multiple surgical laser system beam guide, single-use

Earlens Tympanic Lens, Right - 00850013007578

No Description
EARLENS CORPORATION
ITL01R
In Commercial Distribution

  • 00850013007578 ()
ITL01R

  • Tympanic membrane contact hearing aid tympanic transducer

Earlens Tympanic Lens, Left - 00850013007561

No Description
EARLENS CORPORATION
ITL01L
In Commercial Distribution

  • 00850013007561 ()
ITL01L

  • Tympanic membrane contact hearing aid tympanic transducer

Earlens Ear Tip, Right - 00850013007554

No Description
EARLENS CORPORATION
ET01R
In Commercial Distribution

  • 00850013007554 ()
ET01R

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Ear Tip, Left - 00850013007547

No Description
EARLENS CORPORATION
ET01L
In Commercial Distribution

  • 00850013007547 ()
ET01L

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Processor, Black - 00850013007530

No Description
EARLENS CORPORATION
IPR01BL
In Commercial Distribution

  • 00850013007530 ()
IPR01BL

  • Tympanic membrane contact hearing aid sound processor

Earlens Processor, Silver - 00850013007523

No Description
EARLENS CORPORATION
IPR01SI
In Commercial Distribution

  • 00850013007523 ()
IPR01SI

  • Tympanic membrane contact hearing aid sound processor

Earlens Processor, Champagne - 00850013007516

No Description
EARLENS CORPORATION
IPR01CH
In Commercial Distribution

  • 00850013007516 ()
IPR01CH

  • Tympanic membrane contact hearing aid sound processor

Lateral Mixing Tips - 00850013007509

Lateral Mixing Tip Kit (contains 7 Mixing Tips for 10ml Cartridges)
EARLENS CORPORATION
IDT05
In Commercial Distribution

  • 00850013007448 ()
  • 00850013007509 ()
IDT05

  • Earmould impression kit

Lateral Impression Cartridges - 00850013007493

Lateral Impression Cartridge, 6-pack, IMC04, AS01059
EARLENS CORPORATION
IMC04
In Commercial Distribution

  • 00850013007493 ()
  • 00850013007363 ()
IMC04

  • Earmould impression material

Soft Medial Mixing Tips - 00850013007479

No Description
EARLENS CORPORATION
IDT04
In Commercial Distribution

  • 00850013007486 ()
  • 00850013007479 ()
IDT04

  • Earmould impression kit

Earlens Processor - 00850013007462

Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IPR02XX
Not in Commercial Distribution

  • 00850013007462 ()
IPR02XX

  • Tympanic membrane contact hearing aid sound processor

Soft Tipped Medial Mixing Tip(Blue) - 00850013007424

No Description
EARLENS CORPORATION
IDT03
Not in Commercial Distribution

  • 00850013007424 ()
  • 00850013007455 ()
IDT03

  • Dental material mixing nozzle

Earlens Fidelity Software - 00850013007417

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

Mixing Tips for 10ml Cartirdges - 00850013007400

No Description
EARLENS CORPORATION
IDT02
Not in Commercial Distribution

  • 00850013007400 ()
  • 00850013007448 ()
IDT02

  • Earmould, custom-made

Dispensing Tips (Blue) - 00850013007394

No Description
EARLENS CORPORATION
IDT01
Not in Commercial Distribution

  • 00850013007394 ()
  • 00850013007431 ()
IDT01

  • Dental material mixing nozzle

Impression Dispenser - 00850013007387

No Description
EARLENS CORPORATION
IDG01
In Commercial Distribution

  • 00850013007387 ()
IDG01

  • Earmould impression kit

Medial Impression Cartridges - 00850013007370

Medial Impression Cartridge, 3-Pack, IMC03, AS01052
EARLENS CORPORATION
IMC03
In Commercial Distribution

  • 00850013007356 ()
  • 00850013007370 ()
IMC03

  • Earmould impression material

Earlens Hybrid Impression Kit - 00850013007349

Includes - Medial Impression Cartridges - Lateral Impression Cartridges - Medial Mixing Tips - Lateral Mixing Tips
EARLENS CORPORATION
HIK02
In Commercial Distribution

  • 00850013007349 ()
HIK02

  • Earmould impression kit

Earlens Fitting Software, USB - 00850013007295

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

Earlens Contact Hearing Solution, Binaural - 00850013007288

Inductive Kit containing Left and Right Ear Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IBK01
In Commercial Distribution

  • 00850013007288 ()
IBK01

  • Tympanic membrane contact hearing aid
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