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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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Infusion Pole - 07640143932450

No Description
Schaerer Medical AG
with fixing clamp
In Commercial Distribution

  • 07640143932450 ()
90500

  • Freestanding/bed-attached intravenous pole

Radial setting clamp - 07640143930906

rotating
Schaerer Medical AG
with fixing screw
In Commercial Distribution

  • 07640143930906 ()
90506

  • Medical table clamp

Hand surgery table - 07640143930296

No Description
Schaerer Medical AG
with fixing screw
In Commercial Distribution

  • 07640143930296 ()
90913

  • Arm procedure positioner, reusable

Venous Line Clamp - 04033817900498

No Description
LivaNova Deutschland GmbH
with Remote Control
In Commercial Distribution

  • 04033817900498 ()


  • Cardiopulmonary bypass system, roller type

Revolution CT - 00840682146319

Revolution CT with Apex edition - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
with Apex edition
In Commercial Distribution

  • 00840682146319 ()
5826588

  • Full-body CT system

Restylane - 03770034301059

No Description
UNIVERDERM
Defyne with Lidocaine
In Commercial Distribution

  • 03770034301059 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane - 03770034301042

No Description
UNIVERDERM
Kysse with Lidocaine
In Commercial Distribution

  • 03770034301042 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane - 03770034301028

No Description
UNIVERDERM
Refyne with Lidocaine
In Commercial Distribution

  • 03770034301028 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Little Sucker® and Cover - 10812594011365

The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.
Neotech Products LLC
Preemie with Cover
In Commercial Distribution

  • 10812594011365 ()
  • 00812594011368 ()
N204C

  • Airway suction catheter

Little Sucker® and Cover - 10812594011389

The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.
Neotech Products LLC
Standard with Cover
In Commercial Distribution

  • 10812594011389 ()
  • 00812594011382 ()
N205C

  • Airway suction catheter
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