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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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PRECICE® Intramedullary Limb Lengthening System - 00856719002008

ERC1, MAGEC, Shipping Pkg AR
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
P003
In Commercial Distribution

  • 00856719002008 ()
EAD-P1-001

  • Distraction implant adjustment remote control

MINOCAL - 00856605006103

Whole Blood Hematology Calibrator
HORIBA INSTRUMENTS INCORPORATED
1x2.5mL
In Commercial Distribution

  • 00856605006103 ()
5300100152

  • Full blood count IVD, calibrator

MINOCAL - 00856605006004

Whole Blood Hematology Calibrator
HORIBA INSTRUMENTS INCORPORATED
2x2.5mL
In Commercial Distribution

  • 00856605006004 ()
5300000276

  • Full blood count IVD, calibrator

Proteus Digital Health Feedback System - 00856602005222

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2330
In Commercial Distribution

  • 00856602005222 ()


  • Medication adherence telemetric monitoring system, post-ingestion

Proteus Digital Health Feedback System - 00856602005215

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2329
In Commercial Distribution

  • 00856602005215 ()


  • Medication adherence telemetric monitoring system, post-ingestion

NA - 00856602005154

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2042
In Commercial Distribution

  • 00856602005154 ()


  • Medication adherence telemetric monitoring system ingestible transmitter

Proteus Digital Health Feedback System - 00856602005130

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2005
In Commercial Distribution

  • 10856602005137 ()
  • 00856602005130 ()
  • 20856602005134 ()


  • Medication adherence telemetric monitoring system, post-ingestion

NA - 00856602005017

No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-0800
In Commercial Distribution

  • 10856602005014 ()
  • 00856602005017 ()


  • Medication adherence telemetric monitoring system, post-ingestion

CariFree Fluoride Varnish - 00856596006410

A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Dental Alliance Holdings LLC
Raspberry
Not in Commercial Distribution

  • 00856596006410 ()


  • Dental cavity varnish

CariFree Fluoride Varnish - 00856596006403

A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Dental Alliance Holdings LLC
Mint
Not in Commercial Distribution

  • 00856596006403 ()


  • Dental cavity varnish
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