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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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Multimeter MagicMaX-Universal - EIBAVD02020100

Multimeter MagicMaX developed in accordance with IEC 61674. Flexible solution for exact dose- and kV-measurements at all X-ray units incl. CT.
IBA Dosimetry GmbH
VD0202010
In Commercial Distribution

  • EIBAVD02020100 ()
VD0202010

  • Diagnostic x-ray system quality assurance device

VISICOIL MR Twin Line - EIBAMRTL075820190

2 - 0.75mm x 0.50cm VISICOIL MR separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
MRTL-075-82019
In Commercial Distribution

  • EIBAMRTL075820190 ()
MRTL-075-82019

  • Radiological image marker, implantable

BRILLIANT EverGlow Flow - J00660019758

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in several shades. 1 Syringe a 2g Translucent TS
Coltène/Whaledent AG
60019758
In Commercial Distribution

  • J00660019758 ()
60019758

  • Dental composite resin

BRILLIANT EverGlow Flow - J00660019752

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in several shades. 1 Syringe a 2g UNIVERSAL BL
Coltène/Whaledent AG
60019752
In Commercial Distribution

  • J00660019752 ()
60019752

  • Dental composite resin

BRILLIANT EverGlow Flow - J00660019751

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in several shades. 1 Syringe a 2g Opaque OA2
Coltène/Whaledent AG
60019751
In Commercial Distribution

  • J00660019751 ()
60019751

  • Dental composite resin

QuickProfile™ Drugs of Abuse Test Cup - M90107RD7208110

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI /OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-11
In Commercial Distribution

  • M90107RD7208110 ()

  • Length: 74 Millimeter
07RD7208-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Test Cup - M90107RD7208100

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-10
In Commercial Distribution

  • M90107RD7208100 ()

  • Length: 74 Millimeter
07RD7208-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 8 Test - M90107RD7071200

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-20
In Commercial Distribution

  • M90107RD7071201 ()
  • M90107RD7071200 ()

  • Length: 75 Millimeter
07RD7071-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 8 Test - M90107RD7071120

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-12
In Commercial Distribution

  • M90107RD7071121 ()
  • M90107RD7071120 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

CAPTURE™ - 10381780247739

CAPTURE™ High Torque Screw System The trocar is used during guide pin placement in the Capture high torque screw system.
Ascension Orthopedics, Inc.
TRC-5000-507-070
In Commercial Distribution

  • M269TRC50005070701 ()
  • 10381780247739 ()

  • 101.55 mm L
TRC-5000-507-070

  • Orthopaedic trocar blade, reusable
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