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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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IPS Empress Esthetic - DIVO5745121

mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574512
Not in Commercial Distribution

  • DIVO5745121 ()
  • DIVO5745120 ()
574512

  • Dental appliance fabrication material, ceramic

IPS Empress Esthetic - DIVO5745111

mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574511
Not in Commercial Distribution

  • DIVO5745111 ()
  • DIVO5745110 ()
574511

  • Dental appliance fabrication material, ceramic

Electrode for ABL analyzers - 05700699456632

E8089 Crea B electrode for ABL8XX
Radiometer Medical ApS
945-663
In Commercial Distribution

  • 05700699456632 ()
945-663

  • Creatinine IVD, reagent

Regard™ - 10194717113102

PK CUST C CABG A & B
ROI CPS, LLC
CV00080Y
Not in Commercial Distribution

  • 20194717113109 ()
  • 10194717113102 ()


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

Regard™ - 10194717112624

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932G
Not in Commercial Distribution

  • 20194717112621 ()
  • 10194717112624 ()


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

Regard™ - 10194717110941

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932F
Not in Commercial Distribution

  • 20194717110948 ()
  • 10194717110941 ()


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

Regard™ - 10194717109310

PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932E
Not in Commercial Distribution

  • 20194717109317 ()
  • 10194717109310 ()


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

Medline Industries, Inc. - 10193489965346

CV PACK A B OK HEART
MEDLINE INDUSTRIES, INC.
DYNJ65562C
In Commercial Distribution

  • 10193489965346 ()
DYNJ65562C

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

Medline Industries, Inc. - 10193489791105

PK, OPEN HEART-CABG A/B/C
MEDLINE INDUSTRIES, INC.
DYNJ43544B
In Commercial Distribution

  • 10193489791105 ()
DYNJ43544B

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

Trinity Biotech - 05391516741903

Bile Acids Reagent B (25 mL)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
450-2-25
In Commercial Distribution

  • 05391516741903 ()

  • Total Volume: 25 Milliliter
450-2-25

  • Total bile acid IVD, reagent
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