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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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NTI Universal Cutter E
NTI - Kahla GmbH Rotary Dental Instruments
HF071CE-031
In Commercial Distribution

  • E310HF071CE0311 ()
UC071E-031

  • Carbide dental bur, reusable
NTI Universal Cutter E
NTI - Kahla GmbH Rotary Dental Instruments
HF071CE-027
In Commercial Distribution

  • E310HF071CE0271 ()
UC071E-027

  • Carbide dental bur, reusable
EYELET D & E 10PK
World Class Technology Corporation
500.0002
In Commercial Distribution

  • 00840273917571 ()
500.0002

  • Orthodontic bracket, metal
Explorer S/E Hh
Young Innovations, Inc.
187-750-HH
In Commercial Distribution

  • 10843471101251 ()
  • 00843471101254 ()
187-750-HH

  • Dental surgical probe, reusable
ABC+E Prosthesis (eMax)
STONEGLASS DENTAL LABORATORY PTY LTD
SGI19
In Commercial Distribution

  • D101SGI190 ()
SGI19

  • Dental bridge, metal-ceramic
ZL Home Kit - E
ZEPHYR TECHNOLOGY LLC
9607.0245
Not in Commercial Distribution

  • 10884521712966 ()
9607.0245

  • Electrocardiograph, professional, single-channel
cement spatula d/e
Medicon eG. Chirurgiemechaniker-Genossenschaft
378.12.01
In Commercial Distribution

  • 04046826184292 ()
378.12.01

  • Dental spatula, reusable
SYSTEM JANUS E 4.0
FUJIFILM SONOSITE, INC.
P30381-02
In Commercial Distribution

  • 00841517107918 ()
P30381

  • General-purpose ultrasound imaging system
STERILE E P PK
Cardinal Health 200, LLC
SAN18EPEHU
In Commercial Distribution

  • 50885425346927 ()
  • 10885425346929 ()
SAN18EPEHU

  • Angiography kit
Tibial E/M Guide
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523150649 ()
2203-321-003

  • General internal orthopaedic fixation system implantation kit
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