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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SPDEI-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, 5 Meter hose - Each
MEDIMAX TECH INC.
SPDEI-5
In Commercial Distribution

  • 20817325023485 ()
  • 10817325023488 ()
  • 00817325023481 ()
  • 30817325023482 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPDEI - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, 3 Meter Hose - Each/ elbow type
MEDIMAX TECH INC.
SPDEI
In Commercial Distribution

  • 20817325023478 ()
  • 10817325023471 ()
  • 00817325023474 ()
  • 30817325023475 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPDE-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Non-Stick Blade, 5 Meter hose - Each
MEDIMAX TECH INC.
SPDE-5
In Commercial Distribution

  • 20817325023461 ()
  • 10817325023464 ()
  • 00817325023467 ()
  • 30817325023468 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPDE - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Non-Stick Blade, 3 Meter (10') Hose - elbow type
MEDIMAX TECH INC.
SPDE
In Commercial Distribution

  • 20817325023454 ()
  • 10817325023457 ()
  • 00817325023450 ()
  • 40817325023458 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPSTI-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 5 meter Hose- Each, elbow type
MEDIMAX TECH INC.
SPSTI-5
In Commercial Distribution

  • 10817325023440 ()
  • 00817325023443 ()
  • 20817325023447 ()
  • 30817325023444 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPSTI - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 3 Meter Hose - Each; elbow type
MEDIMAX TECH INC.
SPSTI
In Commercial Distribution

  • 20817325023430 ()
  • 10817325023433 ()
  • 00817325023436 ()
  • 30817325023437 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPST-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 5 meter Hose - Each ; elbow type
MEDIMAX TECH INC.
SPST-5
In Commercial Distribution

  • 20817325023423 ()
  • 10817325023426 ()
  • 00817325023429 ()
  • 30817325023420 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPST - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 3 Meter (10') Hose ; Elbow type
MEDIMAX TECH INC.
SPST
In Commercial Distribution

  • 20817325023416 ()
  • 10817325023419 ()
  • 00817325023412 ()
  • 30817325023413 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with non-stick electrode and holster 1 pc per pack/ 10 pcs per box/ 8 boxes per case.
MEDIMAX TECH INC.
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with Non-Stick
In Commercial Distribution

  • 20817325023409 ()
  • 10817325023402 ()
  • 00817325023405 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EcoEvRNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNHT-15
In Commercial Distribution

  • 20817325023089 ()
  • 10817325023082 ()
  • 00817325023085 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvRNHT-10 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNHT-10
In Commercial Distribution

  • 20817325023072 ()
  • 10817325023075 ()
  • 00817325023078 ()


  • Surgical plume evacuation system
  • Electrosurgical return electrode, single-use
EcoEvRNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNH-15
In Commercial Distribution

  • 20817325023065 ()
  • 10817325023068 ()
  • 00817325023061 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster
MEDIMAX TECH INC.
EcoEvRNH-10
In Commercial Distribution

  • 20817325023058 ()
  • 10817325023051 ()
  • 00817325023054 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNHT-15
In Commercial Distribution

  • 20817325023041 ()
  • 10817325023044 ()
  • 00817325023047 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNHT-10 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNHT-10
In Commercial Distribution

  • 20817325023034 ()
  • 10817325023037 ()
  • 00817325023030 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNH-15
In Commercial Distribution

  • 20817325023027 ()
  • 10817325023020 ()
  • 00817325023023 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNH-10 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNH-10
In Commercial Distribution

  • 20817325023010 ()
  • 10817325023013 ()
  • 00817325023016 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHT-15 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-15
In Commercial Distribution

  • 20817325023003 ()
  • 10817325023006 ()
  • 00817325023009 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-10
In Commercial Distribution

  • 20817325022990 ()
  • 10817325022993 ()
  • 00817325022996 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-15 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-15
In Commercial Distribution

  • 20817325022983 ()
  • 10817325022986 ()
  • 00817325022989 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-10 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-10
In Commercial Distribution

  • 20817325022976 ()
  • 10817325022979 ()
  • 00817325022972 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


  • Bladder-emptying vibratory stimulator
Queen's Square Bladder Stimulator - Selectable (PC9S)
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator
Unloading harness for gait training
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRUHS0 ()


  • Gait rehabilitation system harness
Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


  • Gait rehabilitation system harness
Pediatiric harness for gait training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRPH0 ()


  • Gait rehabilitation system harness
Simple two-loop spotting harness for gait and balance training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRMS0 ()


  • Gait rehabilitation system harness
Harness for Healing Solutions Robotic Trainer
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRHSH0 ()


  • Gait rehabilitation system harness
Balance harness for balance training activities
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRBHS0 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564115
In Commercial Distribution

  • 00887761983816 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564114
In Commercial Distribution

  • 00887761983809 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560118
In Commercial Distribution

  • 00887761983793 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560117
In Commercial Distribution

  • 00887761983786 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560116
In Commercial Distribution

  • 00887761983779 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560115
In Commercial Distribution

  • 00887761983762 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560114
In Commercial Distribution

  • 00887761983755 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560113
In Commercial Distribution

  • 00887761983748 ()


  • Gait rehabilitation system harness
Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution

  • 03700111425866 ()
  • 03700111400863 ()

  • Total Volume: 30 Milliliter
1302001

  • Assisted reproduction cryotube
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
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