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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HYH SHOULDER BOT. W/CON
O&M HALYARD, INC.
05018
In Commercial Distribution

  • 30680651050183 ()
  • 10680651050189 ()
76094-ACM5018

  • Patient surgical drape, single-use
TABLE, VTS (VIBRATORY TISSUE SEPARATOR/SHAKER), 240VAC
The Wells Johnson Company
20182600
In Commercial Distribution

  • B458201826000 ()
20-1826-00

  • Laboratory shaker
TABLE, VTS (VIBRATORY TISSUE SEPARATOR/SHAKER), 120VAC
The Wells Johnson Company
20182500
In Commercial Distribution

  • B458201825000 ()
20-1825-00

  • Laboratory shaker
ASICO ANGLED DIAMOND CRESENT BEVEL BOT
KATENA PRODUCTS, INC.
AE-8152
In Commercial Distribution

  • 00841668141564 ()
AE-8152

  • Ophthalmic knife, reusable
LOW VOL, PRE-PUMP BOT CHAMBER 6.35MM
B. BRAUN MEDICAL INC.
B3-6605M6792
Not in Commercial Distribution

  • 04046955348879 ()
  • 04046955348886 ()
B3-6605M6792

  • Haemodialysis blood tubing set, single-use
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
Not in Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
Not in Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software
iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software
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