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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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No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 5
In Commercial Distribution

  • 08800013520005 ()


  • General-purpose ultrasound imaging system
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
Grid 5
In Commercial Distribution

  • 08806088508931 ()


  • Stationary x-ray grid
Irrigating Cystotome 25g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5003AF.5
In Commercial Distribution

  • 00840516126562 ()
  • 00840516127620 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Irrigating Cystotome 25g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5003AF.5
In Commercial Distribution

  • 00840516126562 ()
  • 00840516127095 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Hybrid Dressing 10x40 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1040/5
In Commercial Distribution

  • 10849405002182 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Irrigating Cystotome 25g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5003AF.5
In Commercial Distribution

  • 00840516129594 ()
  • 00840516128177 ()
  • 00840516130095 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901402 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901396 ()


  • Cardiopulmonary bypass system, roller type
No Description
AMERICAN EAGLE INSTRUMENTS, INC.
AEOVSWV8/5
In Commercial Distribution

  • 00841013109324 ()


  • Instrument tray, reusable
ECG Electrodes
Leonhard Lang GmbH
F-RE /5
In Commercial Distribution

  • 30853512006029 ()
  • 20853512006022 ()
  • 10853512006025 ()
  • 00853512006028 ()
5535

  • Electrocardiographic electrode, single-use
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