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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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OWANDY ONE SIZE 2
OWANDY RADIOLOGY
ONE #2
In Commercial Distribution

  • 03760262651125 ()
9458600200

  • Dental digital imaging sensor, intraoral
A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.
BTE TECHNOLOGIES, INC.
MCU 2
In Commercial Distribution

  • 10850390007427 ()


  • Neck mechanical weight exerciser
No Description
VARIAN MEDICAL SYSTEMS, INC.
Channel 2
In Commercial Distribution

  • 00816389028517 ()
  • 10816389028514 ()
Not Sold Separately

  • General-purpose brachytherapy system applicator, remote-afterloading
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
IRRIGATING CYSTOTOME 25g X 16mm (5/8") FORMED
Psi/Eye-Ko, Inc.
5003AF.2
In Commercial Distribution

  • 00840516131733 ()
  • 00840516131726 ()
  • 00840516131740 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
IRRIGATING CYSTOTOME 25g X 16mm (5/8") FORMED
Psi/Eye-Ko, Inc.
5003AF.2
In Commercial Distribution

  • 00840516131696 ()
  • 00840516131719 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
IRRIGATING CYSTOTOME 25g X 16mm (5/8") FORMED
Psi/Eye-Ko, Inc.
5003AF.2
In Commercial Distribution

  • 00840516131696 ()
  • 00840516131702 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Irrigating Cystotome 27g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5001AF.2
In Commercial Distribution

  • 00840516129563 ()
  • 00840516128122 ()
  • 00840516130064 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Irrigating Cystotome 27g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5001AF.2
In Commercial Distribution

  • 00840516126531 ()
  • 00840516127590 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Irrigating Cystotome 27g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5001AF.2
In Commercial Distribution

  • 00840516126531 ()
  • 00840516127064 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
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