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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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MTO LEFT HEART KIT - SOUTH BAY HOSP PG
MEDLINE INDUSTRIES, INC.
60191292
In Commercial Distribution

  • 20193489050803 ()
  • 10193489050806 ()
60191292

  • Angiography kit
10M - State of South Dakota DOT BBP - Metal
Certified Safety Manufacturing, Inc.
FK412-001
In Commercial Distribution

  • 00766588120010 ()
FK412-001

  • Cardiopulmonary resuscitation mask, single-use
  • First aid kit, medicated
  • Non-rebreathing valve, single-use
PlasmaJet Ultra Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-3130IS-ZA
In Commercial Distribution

  • M397PS103130ISZA0 ()
PS10-3130IS-ZA

  • Plasma surgical system
PlasmaJet V3 Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-2130IS-ZA
In Commercial Distribution

  • M397PS102130ISZA0 ()
PS10-2130IS-ZA

  • Plasma surgical system
*CUSTOM* South Metro IV Admin 10 drop kit
BOUND TREE MEDICAL, LLC
8600-01354
In Commercial Distribution

  • 00812277033069 ()
8600-01354

  • Peripheral vascular intervention infusion catheter
Pack Vein F/ Cardiovascular Specialists of South Florida
HENRY SCHEIN, INC.
5703723
In Commercial Distribution

  • 00304040180464 ()
  • 10304040180461 ()
5703723

  • General surgical procedure kit, non-medicated, single-use
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFF73, 12x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2749
In Commercial Distribution

  • 30607915134212 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
MESURING PROBE PERIODONTIC, ZEPF ESSENTIAL BIONIK LIGHTRED-MAGENTA PA PROBE CAROLINA CNC, PROBE FIG 3A
Helmut Zepf Medizintechnik GmbH
24.854.24
In Commercial Distribution

  • EZPF24854240 ()
24.854.24

  • Periodontal curette
MESURING PROBE PERIODONTIC, ZEPF ESSENTIAL BIONIK COBALT-BLUE PA PROBE CAROLINA CNC, PROBE FIG 3A
Helmut Zepf Medizintechnik GmbH
24.854.14
In Commercial Distribution

  • EZPF24854140 ()
24.854.14

  • Periodontal curette
DBIL (Direct Bilirubin) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC229
Not in Commercial Distribution

  • 00817302020601 ()

  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 75 Milliliter
CC229

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
DBIL (Direct Bilirubin) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-229
In Commercial Distribution

  • 00817302020595 ()

  • Total Volume: 47 Milliliter
  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 7 Milliliter
AU-229

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
DBIL (Direct Bilirubin) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL229
In Commercial Distribution

  • 00817302020588 ()

  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 5 Milliliter
  • Total Volume: 25 Milliliter
BL229

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
DBIL (Direct Bilirubin) 4 x 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST229
In Commercial Distribution

  • 00817302020571 ()

  • Total Volume: 54 Milliliter
  • Total Volume: 10 Milliliter
  • Kit contains 4 R1, 4 R2 & 1 package insert
ST229

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
CREA3 (Creatinine) - Modular & CX3 Reagent 3 x 2000 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88809
In Commercial Distribution

  • 00817302020564 ()

  • Kit containts 3 R1, 3 R2 bottles and 1 package insert
  • Total Volume: 400 Milliliter
  • Total Volume: 1600 Milliliter
88809

  • Creatinine IVD, kit, spectrophotometry
CREA (Creatinine) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-243
In Commercial Distribution

  • 00817302020540 ()

  • Total Volume: 45 Milliliter
  • Total Volume: 11 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
AU-243

  • Creatine IVD, kit, spectrophotometry
CO2 (Carbon Dioxide) Alkaline w/ cal - Modular & CX3 Reagent 1 x 500 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88813
In Commercial Distribution

  • 00817302020533 ()

  • Total Volume: 500 Milliliter
  • Kit contains 1 R1 and 1 package insert
88813

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
CO2 (Carbon Dioxide) Acid w/ cal - Modular & CX3 Reagent 1 x 2000 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88812
In Commercial Distribution

  • 00817302020526 ()

  • Kit contains 1 R1 and 1 package insert
  • Total Volume: 2000 Milliliter
88812

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
CK (Creatine Kinase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC207
In Commercial Distribution

  • 00817302020519 ()

  • Total Volume: 60 Milliliter
  • Total Volume: 10 Milliliter
  • Kit contains 2 reagent cartridges and 1 package insert
CC207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
CK (Creatine Kinase) 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-207
In Commercial Distribution

  • 00817302020502 ()

  • Total Volume: 35 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 9 Milliliter
AU-207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
CK (Creatine Kinase) 4 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST207
In Commercial Distribution

  • 00817302020489 ()

  • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
  • Total Volume: 56 Milliliter
  • Total Volume: 17 Milliliter
ST207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
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