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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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KneeAlign 2 - 00858704006022

KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-04
In Commercial Distribution

  • 00858704006022 ()
402064-04

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006015

Reference Sensor 2
Orthalign, Inc.
133632
In Commercial Distribution

  • 00858704006015 ()
133632

  • Orthopaedic stereotactic surgery system

Genius 2 - 00697077002596

No Description
Amico Diagnostic Incorporated
TT-F-IR
Not in Commercial Distribution

  • 00697077002596 ()


  • Infrared patient thermometer, ear

Genius 2 - 00697077001933

No Description
Amico Diagnostic Incorporated
TT-D-IR
Not in Commercial Distribution

  • 00697077001933 ()


  • Infrared patient thermometer, ear

Genius 2 - 00697077001926

No Description
Amico Diagnostic Incorporated
TT-A-IR
Not in Commercial Distribution

  • 00697077001926 ()


  • Infrared patient thermometer, ear

FlexPress 2 - 00714196792020

No Description
DERMARITE INDUSTRIES LLC
79202
In Commercial Distribution

  • 00714196792020 ()


  • Compression bandaging kit

Visica 2 - 00868390000211

The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.
SANARUS TECHNOLOGIES, INC.
VS3000
In Commercial Distribution

  • 00868390000211 ()
VS3000

  • General cryosurgical system, cryogen gas, electronic

Centauri 2 - 00860013851552

Portable Halogen Headlight
QED, INC.
QED-9500
In Commercial Distribution

  • 00860013851552 ()


  • Head-worn lamp

Dilator 2 - 00855369008491

Dilator 2
Si-Bone Inc.
501161
In Commercial Distribution

  • 00855369008491 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Decorticator 2 - 00855369008217

Decorticator 2
Si-Bone Inc.
400222
In Commercial Distribution

  • 00855369008217 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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