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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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X-Series - 00851113007895

X24 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS24-4321
In Commercial Distribution

  • 00851113007895 ()


  • Analytical scalp electrode, single-use

X-Series - 00851113007888

X10 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS10-4321
In Commercial Distribution

  • 00851113007888 ()


  • Analytical scalp electrode, single-use

X-Series - 00851113007451

Synapse Cream Kit
ADVANCED BRAIN MONITORING, INC.
XS02-4351
In Commercial Distribution

  • 00851113007451 ()


  • Electrode conductive medium

ARCHITECT - 00380740002091

ARCHITECT Folate Calibrators
ABBOTT IRELAND
1P74-02
In Commercial Distribution

  • 00380740002091 ()
01P7402

  • Folate (vitamin B9) IVD, calibrator

BISICO Cem DC A3 - EBIB752401

Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75240
In Commercial Distribution

  • EBIB752401 ()
75240

  • Dental composite resin

BISICO Repo-Core DC A3 25ml - EBIB752201

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75220
In Commercial Distribution

  • EBIB752201 ()
75220

  • Dental composite resin

BISICO Repo-Core DC A3 Mini - EBIB752001

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75200
In Commercial Distribution

  • EBIB752001 ()
75200

  • Dental composite resin

BISICO Cementime DC - EBIB037301

Dual-curing, semipermanent luting cement for crowns and bridges on dental implants
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03730
In Commercial Distribution

  • EBIB037301 ()
03730

  • Ethoxy benzoic acid dental cement

Research and Diagnostic Systems - 10815762021685

Quantikine Erythropoietin Control 3 (10 vials)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CEP03
In Commercial Distribution

  • 10815762021685 ()
  • 00815762021688 ()
CEP03

  • Erythropoietin (EPO) IVD, control

Research and Diagnostic Systems - 00815762021671

Quantikine Erythropoietin Control 1 & 2 (5 vials of each)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CEP01
In Commercial Distribution

  • 00815762021671 ()
CEP01

  • Erythropoietin (EPO) IVD, control
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