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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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CARDINAL HEALTH - 10888439503661

LACERATION WITH INSTMTS TRAY
Cardinal Health 200, LLC
16-2503B
In Commercial Distribution

  • 50888439503669 ()
  • 10888439503661 ()
16-2503B

  • General surgical procedure kit, non-medicated, single-use

APEX - 04713025000080

XT Auto with Humidifier
Wellell Inc.
9S-005720, 9S-006500
In Commercial Distribution

  • 14713025000087 ()
  • 04713025000080 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000066

XT Prime with Humidifier
Wellell Inc.
9S-005580, 9S-006500
In Commercial Distribution

  • 14713025000063 ()
  • 04713025000066 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000042

XT Sense with Humidifier
Wellell Inc.
9S-005530, 9S-006500
In Commercial Distribution

  • 14713025000049 ()
  • 04713025000042 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000028

XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • Home CPAP unit
  • Heated respiratory humidifier

CARDINAL HEALTH - 10888439463835

CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CREC4
In Commercial Distribution

  • 50888439463833 ()
  • 10888439463835 ()
SNE69CREC4

  • Craniotomy kit

CARDINAL HEALTH - 10888439463477

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC5
In Commercial Distribution

  • 50888439463475 ()
  • 10888439463477 ()
SNE69LMEC5

  • Neurosurgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439746341

MINOR BASIN WITH GOWN
Cardinal Health 200, LLC
SBA22MBGC1
In Commercial Distribution

  • 50888439746349 ()
  • 10888439746341 ()
SBA22MBGC1

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439687323

SCOPE PACK WITH POUCH
Cardinal Health 200, LLC
SOP13SPBF1
In Commercial Distribution

  • 50888439687321 ()
  • 10888439687323 ()
SOP13SPBF1

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Tissue-Tek® SmartWrite® - 00615233082374

Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner
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