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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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Polyaxial screw reduct., w/o cannulation 7.5mm/60mm
mahe medical gmbh
PSR11-7560
In Commercial Distribution

  • EMAHPSR1175601 ()
  • EMAHPSR1175600 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 7.5 Millimeter
PSR11-7560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/55mm
mahe medical gmbh
PSR11-7555
In Commercial Distribution

  • EMAHPSR1175551 ()
  • EMAHPSR1175550 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55.0 Millimeter
PSR11-7555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/50mm
mahe medical gmbh
PSR11-7550
In Commercial Distribution

  • EMAHPSR1175501 ()
  • EMAHPSR1175500 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50.0 Millimeter
PSR11-7550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/45mm
mahe medical gmbh
PSR11-7545
In Commercial Distribution

  • EMAHPSR1175451 ()
  • EMAHPSR1175450 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 45.0 Millimeter
PSR11-7545

  • Bone-screw internal spinal fixation system, non-sterile
Set screw f.polyaxial screws
mahe medical gmbh
CHM01-11
In Commercial Distribution

  • EMAHCHM01111 ()
  • EMAHCHM01110 ()
CHM01-11

  • Bone-screw internal spinal fixation system, non-sterile
Set screw w.plate f.polyaxial screws
mahe medical gmbh
CHM01-10
In Commercial Distribution

  • EMAHCHM01101 ()
  • EMAHCHM01100 ()

  • Width: 6.6 Millimeter
CHM01-10

  • Bone-screw internal spinal fixation system, non-sterile
Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer 6 pcs./unit
mahe medical gmbh
KM71-880
In Commercial Distribution

  • EMAHKM718801 ()
  • EMAHKM718800 ()
  • EMAHKM718802 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 229.0 Millimeter
KM71-880

  • Orthopaedic bone pin, non-bioabsorbable
Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit
mahe medical gmbh
KM71-513
In Commercial Distribution

  • EMAHKM715131 ()
  • EMAHKM715130 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 229 Millimeter
KM71-513

  • Orthopaedic bone pin, non-bioabsorbable
Steinmann pin w. trocar/round end 2.0mm/229mm, 6 pcs./unit
mahe medical gmbh
KM71-510
In Commercial Distribution

  • EMAHKM715101 ()
  • EMAHKM715100 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 229 Millimeter
KM71-510

  • Orthopaedic bone pin, non-bioabsorbable
Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit
mahe medical gmbh
KM71-459
In Commercial Distribution

  • EMAHKM714591 ()
  • EMAHKM714590 ()
  • EMAHKM714592 ()

  • Length: 229.0 Millimeter
  • Outer Diameter: 3.2 Millimeter
KM71-459

  • Orthopaedic bone pin, non-bioabsorbable
Celluleaf - Surgical tool for subcutaneous blunt release of fibrous septae in soft tissues. The device is delivered sterile and intended for single use.
Aliform B.V.
CELL001
In Commercial Distribution

  • 08721325283047 ()
  • 08721325283054 ()


  • General-purpose curette
Suction Tubing Set 2 m
Assamed GmbH - Medizinbedarf
05354500
In Commercial Distribution

  • 14251783104185 ()
  • 04251783104188 ()
  • 24251783104182 ()

  • Length: 2 Meter


  • Surgical irrigation tubing set, single-use
03 pieces sets for embryo transfer
LABORATOIRE CCD
T.D.T.®SET
In Commercial Distribution

  • 03700111425064 ()
  • 03700111400061 ()

  • Catheter Length: 26.4 Centimeter
  • Outer Diameter: 0.1 Centimeter
1308000

  • Assisted reproduction transfer catheter trial
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • M727SAM450P ()


  • Non-rechargeable public semi-automated external defibrillator
Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
HemaPrompt fecal occult blood test
AERSCHER, INC
HP
In Commercial Distribution

  • 00693501000220 ()
  • 00069350100022 ()


  • Faecal occult blood IVD, reagent
HemaPrompt FG Fecal and Gastric Test Kit
AERSCHER, INC
HPFG
In Commercial Distribution

  • 00693501000152 ()
  • 00069350100015 ()


  • Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Resin root canal sealer for dental endodontic treatment
MICRO MEGA
none
In Commercial Distribution

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
BANDTITE GLASS IONOMER POWDER 100 GMS
AMERICAN ORTHODONTICS CORPORATION
001-972
In Commercial Distribution

  • 00190746007873 ()
001-972

  • Orthodontic bracket adhesive
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