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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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Edge One Glide Path - 00819514026136

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOGP21
In Commercial Distribution

  • 10819514026133 ()
  • 00819514026136 ()
EOGP21

  • Rotary/reciprocating endodontic file/rasp, single-use

Signature ONE Software Package - 00889024647046

v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647046 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647039

v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024585393

v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024585393 ()
302.4018

  • Radiology DICOM image processing application software

Basic One Source Kit - M896AMS3500

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS350
In Commercial Distribution

  • M896AMS3500 ()
  • M896AMS3501 ()
AMS350

  • Haematological concentrate system preparation kit, platelet concentration

Complete One Source Kit - M896AMS3120

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS312
In Commercial Distribution

  • M896AMS3120 ()
  • M896AMS3121 ()
AMS312

  • Haematological concentrate system preparation kit, platelet concentration

Complete one source kit - M896AMS3100

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS310
In Commercial Distribution

  • M896AMS3101 ()
  • M896AMS3100 ()
AMS310

  • Haematological concentrate system preparation kit, platelet concentration

Complete one source kit - M896TRU3100

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU310
Not in Commercial Distribution

  • M896TRU3100 ()
  • M896TRU3101 ()
TRU310

  • Haematological concentrate system preparation kit, platelet concentration

Basic One Source Kit - M896MAR05050

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0505
In Commercial Distribution

  • M896MAR05050 ()
MAR0505

  • Haematological concentrate system preparation kit, platelet concentration

Mirage Prime One Kit - MPOK11

Dentine Bonding Kit
CHAMELEON DENTAL PRODUCTS, INC
POK
In Commercial Distribution

  • MPOK11 ()


  • Dentine bonding agent/set
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