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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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EZCare™ Softouch - 10812594012256

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
5" Tan
In Commercial Distribution

  • 00812594012259 ()
  • 10812594012256 ()
N9105TN

  • Tracheostomy tube neck holder, single-use

EZCare™ Softouch - 10812594012188

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
5" Pink
In Commercial Distribution

  • 00812594012181 ()
  • 10812594012188 ()
N9105PK

  • Tracheostomy tube neck holder, single-use

NA - 08806088508931

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

Anodyne Surgical - 00840516127620

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

Anodyne Surgical - 00840516127095

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

Anodyne Surgical - 00840516128177

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

American Eagle Instruments - 00841013109324

No Description
AMERICAN EAGLE INSTRUMENTS, INC.
AEOVSWV8/5
In Commercial Distribution

  • 00841013109324 ()


  • Instrument tray, reusable

EASYSQUEEZE - 03701430100601

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100601 ()


  • Syringe radiation shield

Easyview LE - 03701430100496

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100496 ()


  • Syringe radiation shield

Mediclic HE - 03701430100113

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100113 ()


  • Syringe radiation shield
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