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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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Globe Scientific - 00840095604673

Inoculation Loop, Rigid, 1uL with Needle, with Calibration Certificate, STERILE, Blue, Individually Wrapped
GLOBE SCIENTIFIC INC.
2851
In Commercial Distribution

  • 00840095604673 ()
  • 00840095610858 ()
  • 00840095604680 ()
  • 00840095680608 ()


  • Inoculating tool IVD, manual

Femtosecond Dbl Ended Spatula - 08175700136839

Femtosecond Dbl Ended Spatula, 1.0mmSpatula with Pointed Tip/ 2.0mm Spatula with Pointed Tip
AURORA SURGICAL, LLC
AS8-301S
In Commercial Distribution

  • 08175700136839 ()
AS8-301S

  • Ophthalmic surgical probe, reusable

Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB - 10607567114217

Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
DATASCOPE CORP.
0884-00-0019-17U
In Commercial Distribution

  • 10607567114217 ()

  • Catheter Gauge: 8 French
0884-00-0019-17U

  • Vascular catheter introduction set, nonimplantable

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB - 10607567114170

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
DATASCOPE CORP.
0884-00-0019-12U
In Commercial Distribution

  • 10607567114170 ()

  • Catheter Gauge: 7.5 French
0884-00-0019-12U

  • Vascular catheter introduction set, nonimplantable

Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB - 10607567107493

Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
DATASCOPE CORP.
0884-00-0019-17
In Commercial Distribution

  • 10607567107493 ()

  • Catheter Gauge: 8 French
0884-00-0019-17

  • Vascular catheter introduction set, nonimplantable

CODMAN® HAKIM® - 10381780535461

Programmable Micro Valve with Unitized RICKHAM® Reservoir with 2cm Arm (Metal Base)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS0358
In Commercial Distribution

NS-0358

  • Cerebrospinal fluid shunt valve

TAP Tubing Set - 00817183020356

True Abdominal Pressure Tubing Set for use with Laparoscopic Insufflators with TAP feature.
NORTHGATE TECHNOLOGIES INC.
7-510-31
In Commercial Distribution

  • 10817183020353 ()
  • 00817183020356 ()


  • Endoscopic insufflation tubing set, single-use

Insufflation Tubing, Gen Use 15/22mm - 00817183020349

Insufflation Tubing for use with Laparoscopic Insufflators with a 15 or 22mm connection
NORTHGATE TECHNOLOGIES INC.
7-510-46
In Commercial Distribution

  • 10817183020346 ()
  • 00817183020349 ()


  • Endoscopic insufflation tubing set, single-use

MediMax Tech - 00817325023054

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

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB - 10607567106632

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
DATASCOPE CORP.
0884-00-0019-12
In Commercial Distribution

  • 10607567106632 ()

  • Catheter Gauge: 7.5 French
0884-00-0019-12

  • Vascular catheter introduction set, nonimplantable
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