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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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SHOULDER COIL N.5 - 08056304453310

Coil for E-scan XQ
ESAOTE SPA
9102206000
In Commercial Distribution

  • 08056304453310 ()


  • MRI system coil, radio-frequency

Pacetrak Plus Rev 5 - B147PACETRAKPLUSENR0

Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR)
In Commercial Distribution

  • B147PACETRAKPLUSENR0 ()


  • Electrocardiography telemetric monitoring system

Heartrak Smart Rev 5 - B147HTSM50

Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Heartrak Smart Rev 5
In Commercial Distribution

  • B147HTSM50 ()


  • Electrocardiography telemetric monitoring system

BIOCRYL ICE 5# POLYMER - D7750470050

No Description
Great Lakes Dental Technologies, Ltd.
047-005
In Commercial Distribution

  • D7750470050 ()


  • Dental prosthesis restorative material, unfilled resin

BIOCRYL ICE 5# KIT - D7750470020

No Description
Great Lakes Dental Technologies, Ltd.
047-002
In Commercial Distribution

  • D7750470020 ()


  • Dental prosthesis restorative material, unfilled resin

truSculpt 5 RF handpiece - 00816722022486

truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device
CUTERA, INC.
truSculpt 5 RF handpiece
In Commercial Distribution

  • 00816722022486 ()


  • Radio-frequency skin contouring system applicator, monopolar

Omnipod 5 Controller APP - 10385083000565

Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Starter Kit - 10385083000503

Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385083000336

Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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