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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BOT TRAY FEM 2 INST CASE
Exactech, Inc.
201-55-23
In Commercial Distribution

  • 10885862238849 ()
201-55-23

  • Instrument tray, reusable
CoRoent XL-F Instrument Tray (Bot Tray)
Nuvasive, Inc.
5450063
In Commercial Distribution

  • 00887517247964 ()


  • Device sterilization/disinfection container, reusable
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
IOS external fixator system (short)
METAPHYSIS LLP
2-0-0S
In Commercial Distribution

  • 05060309872017 ()


  • External orthopaedic fixation system, single-use
IOS external fixator system (Long)
METAPHYSIS LLP
2-0-0L
In Commercial Distribution

  • 05060309872000 ()


  • External orthopaedic fixation system, single-use
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe
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
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