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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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AWI - 06957277200388

EXTREMITY IRRIGATION BAG
Apex (Guangzhou) Tools & Orthopedics Co.
210-05
In Commercial Distribution

  • 06957277200388 ()


  • Closed-wound/centesis drainage receptacle

AWI - 06957277200371

STANDARD TIP
Apex (Guangzhou) Tools & Orthopedics Co.
209-00-68
In Commercial Distribution

  • 06957277200371 ()
  • 16957277200354 ()


  • Surgical irrigation system nozzle

itool® ApexPulse™ - 06957277200098

Hip Kit
Apex (Guangzhou) Tools & Orthopedics Co.
201-04-00
In Commercial Distribution

  • 06957277200098 ()
  • 16957277200095 ()
201-04-00

  • Disposable surgical irrigation/aspiration system

itool® ApexPulse™ - 06957277200081

Knee Kit
Apex (Guangzhou) Tools & Orthopedics Co.
201-03-00
In Commercial Distribution

  • 06957277200081 ()
  • 16957277200088 ()
201-03-00

  • Disposable surgical irrigation/aspiration system

itool® ApexPulse™ - 06957277200074

Component Kit
Apex (Guangzhou) Tools & Orthopedics Co.
201-02-00
In Commercial Distribution

  • 06957277200074 ()
  • 16957277200071 ()
201-02-00

  • Disposable surgical irrigation/aspiration system

Radixact®, Treatment Delivery Console (TDC) - M65810577270

Software, Version 1.0.0.4, Treatment Delivery Console, Radixact (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1057727
In Commercial Distribution

  • M65810577270 ()
NA

  • Linear accelerator system

360CAS - B432360CAS2200

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.2.0
In Commercial Distribution

  • B432360CAS2200 ()


  • Robotic surgical navigation system application software

VITEK®2 - 03573026555504

VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution

  • 03573026555504 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

AlignRT Plus - 05056190500986

No Description
VISION RT LIMITED
HP Z2 G9 workstation - AlignRT Offline
In Commercial Distribution

  • 05056190500986 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500979

No Description
VISION RT LIMITED
HP Z2 G9 workstation - Patient Data Workstation
In Commercial Distribution

  • 05056190500979 ()


  • Radiological video camera patient positioning/tracking system
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