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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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24MM PLANER
CPM Medical Consultants, LLC
FO-2021-24
In Commercial Distribution

  • B565FO2021241 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
2.0 MM K-WIRE, 9 INCH Guide wire Trocar
CPM Medical Consultants, LLC
FO-2013-209
In Commercial Distribution

  • B565FO20132090 ()
FO-2013-209

  • Orthopaedic intraoperative positioning pin, single-use
24mm VI Hourglass Staple
CPM Medical Consultants, LLC
FO-1001-2414
In Commercial Distribution

  • B565FO100124140 ()
FO-1001-2414

  • Orthopaedic bone staple, non-adjustable
24mm VI Hourglass Staple
CPM Medical Consultants, LLC
FO-1000-2416
In Commercial Distribution

  • B565FO100024160 ()


  • Orthopaedic bone staple, non-adjustable
24mm Round Staple
CPM Medical Consultants, LLC
FO-1000-2414
In Commercial Distribution

  • B565FO100024140 ()


  • Orthopaedic bone staple, non-adjustable
20mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100020120 ()
FO-1000-2012

  • Orthopaedic bone staple, non-adjustable, non-sterile
16mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100016100 ()
FO-1000-1610

  • Orthopaedic bone staple, non-adjustable, non-sterile
12mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100012080 ()
FO-1000-1208

  • Orthopaedic bone staple, non-adjustable, non-sterile
No Description
NARVA Lichtquellen GmbH + Co KG.
F12 T5 15W PH / BiPin
Not in Commercial Distribution

  • 84014501000027 ()
  • 54014501500021 ()
  • 04014501000021 ()
10044

  • Ultraviolet tanning device
Ultrasound Doppler Device with CO2 measuring module
Compumedics Germany GmbH
MDX R12 CO2
In Commercial Distribution

  • 04260493310031 ()
7882

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
Ultrasound Doppler Device
Compumedics Germany GmbH
MDX R12
In Commercial Distribution

  • 04260493310017 ()
7880

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.
FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
Frontier X Plus
In Commercial Distribution

  • 08908013617128 ()


  • Electrocardiographic long-term ambulatory recording analyser
  • Telemetric electrocardiographic ambulatory recorder
  • Electrocardiograph, home-use
No Description
ASAHI INTECC CO., LTD.
AIN-CKX-10-200-R
In Commercial Distribution


  • Outer Diameter: 0.01 Inch
  • Length: 200 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
The FCR CARBON X (CR-IR 357) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 357
In Commercial Distribution

  • 04547410265903 ()


  • Computed radiography digital imaging scanner
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
G2-PX
In Commercial Distribution

  • 00850001456548 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
Dental Savings Club Inc
MISTER-X-R#1
In Commercial Distribution

  • D9021050013 ()


  • Dental digital imaging sensor, intraoral
Gemini Vinyl/Nitrile Blend Exam Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XXL-1000
In Commercial Distribution

  • 00850044884360 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size XL Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XL-1000
In Commercial Distribution

  • 00850044884353 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size L Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-L-1000
In Commercial Distribution

  • 00850044884346 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size M Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-M-1000
In Commercial Distribution

  • 00850044884339 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size XXL
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XXL-100
In Commercial Distribution

  • 00850044884322 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-XXL-2000
In Commercial Distribution

  • 00850044884315 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XL Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-XL-2000
In Commercial Distribution

  • 00850044884308 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size L Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-L-2000
In Commercial Distribution

  • 00850044884292 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size M Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-M-2000
In Commercial Distribution

  • 00850044884285 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size S Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-S-2000
In Commercial Distribution

  • 00850044884230 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XXL-1000
In Commercial Distribution

  • 00850044884223 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size XL Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XL-1000
In Commercial Distribution

  • 00850044884216 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size L Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-L-1000
In Commercial Distribution

  • 00850044884209 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size S Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-M-1000
In Commercial Distribution

  • 00850044884193 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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