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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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ABBOTT PRISM - 00380740138394

ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD

Orthex - 00841132179772

Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation system, single-use

Alaris - 10885403960123

Alaris Systems Manager v12-12.5.1
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403960123 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403897535

Alaris Systems Maintenance v12.3-v.12.5
CAREFUSION 303, INC.
8975
In Commercial Distribution

  • 10885403897535 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403897511

Alaris Systems Maintenance
CAREFUSION 303, INC.
8975
Not in Commercial Distribution

  • 10885403897511 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403896125

Alaris Guardrails Editor 12-12.1.3
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403896125 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403896118

Alaris Guardrails Editor 10.X
CAREFUSION 303, INC.
8961
Not in Commercial Distribution

  • 10885403896118 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403520020

Alaris Guardrails Editor 12.1.4
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403520020 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403519666

Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403510489

Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
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