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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*CUSTOM* South Metro Introcan IV Catheter 22ga
BOUND TREE MEDICAL, LLC
8600-01352
In Commercial Distribution

  • 00812277033045 ()
8600-01352

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 20ga
BOUND TREE MEDICAL, LLC
8600-01351
In Commercial Distribution

  • 00812277033038 ()
8600-01351

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 18ga
BOUND TREE MEDICAL, LLC
8600-01350
In Commercial Distribution

  • 00812277033021 ()
8600-01350

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 16ga
BOUND TREE MEDICAL, LLC
8600-01349
In Commercial Distribution

  • 00812277033014 ()
8600-01349

  • Peripheral vascular intervention infusion catheter
*CUSTOM* South Metro Introcan IV Catheter 14ga
BOUND TREE MEDICAL, LLC
8600-01348
In Commercial Distribution

  • 00812277033007 ()
8600-01348

  • Peripheral vascular intervention infusion catheter
Personal Use Kit OC-Auto, for Kaiser South
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS
In Commercial Distribution

  • 00816917024974 ()


  • Faecal occult blood IVD, reagent
PlasmaJet Ultra Plus Console System (South Africa)
PLASMA SURGICAL, INC
PS10-3130-ZA
In Commercial Distribution

  • M397PS103130ZA0 ()
PS10-3130-ZA

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

  • M397PS102130ZA0 ()
PS10-2130-ZA

  • Plasma surgical system
CUSTOM PACK BB11W58R1 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R1
In Commercial Distribution

  • 00763000652906 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11W58R3 BAP SOUTH E C
MEDTRONIC, INC.
BB11W58R3
In Commercial Distribution

  • 00763000963705 ()


  • Cardiopulmonary bypass system blood tubing set
STRL ACL ACCESS T R V SOUTH
Cardinal Health 200, LLC
SOP33ATGHE
In Commercial Distribution

  • 50885425725210 ()
  • 00885425725215 ()
SOP33ATGHE

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Periodontal Probe # CP15 "N. Carolina" graduated; 1-2...-14-15 mm COMFORT | SL | single ended
devemed GmbH
02-2525-40 C
In Commercial Distribution

  • 04061644035090 ()


  • Periodontal probe, reusable
Periodontal Probe # CP15 "N. Carolina" graduated; 1-2...-14-15 mm F-LINE | SL | single ended
devemed GmbH
2525-40 F
In Commercial Distribution

  • 04061644021840 ()


  • Periodontal probe, reusable
MESURING PROBE PERIODONTIC, BIONIK HANDLE LIGHTRED-MAGENTA PA PROBE CAROLINA CNC, PROBE FIG 16
Helmut Zepf Medizintechnik GmbH
24.853.24
In Commercial Distribution

  • EZPF24853240 ()
24.853.24

  • Dental surgical probe, reusable
MESURING PROBE PERIODONTIC, BIONIK HANDLE COBALT-BLUE PA PROBE CAROLINA CNC, PROBE FIG 16
Helmut Zepf Medizintechnik GmbH
24.853.14
In Commercial Distribution

  • EZPF24853140 ()
24.853.14

  • Dental surgical probe, reusable
MEASURING PROBE PERIODONTIC, NORTH CAROLINA, CNC, 1-15MM, TITANIUM IN BIONIK HANDLE, SINGLE-ENDED, M2,5
Helmut Zepf Medizintechnik GmbH
24.216.06
In Commercial Distribution

  • EZPF24216060 ()
24.216.06

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

  • 20193489050803 ()
  • 10193489050806 ()
60191292

  • Angiography kit
MEDIUM TIP WITH 90° BEND SOUTH, POLISHED FINISH
PMT CORPORATION
3201-09M-09-97-PF
In Commercial Distribution

  • 00650551142355 ()

  • Length: 9 Inch
  • Catheter Gauge: 9 French
3201-09M-09-97-PF

  • Surgical irrigation/aspiration handpiece, reusable
MEDIUM TIP WITH 90° BEND SOUTH, POLISHED FINISH
PMT CORPORATION
3201-07M-09-97-PF
In Commercial Distribution

  • 00650551142331 ()

  • Length: 9 Inch
  • Catheter Gauge: 7 French
3201-07M-09-97-PF

  • Surgical irrigation/aspiration handpiece, reusable
EVERFLO w/Oxygen Percentage Indicator, 230V, South Africa
Respironics, Inc.
EVERFLO w/Oxygen Percentage Indicator, 230V, ZA
In Commercial Distribution

  • 00606959032583 ()
1020009

  • Stationary oxygen concentrator
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 Urine Collection for South Shore Hospital Only
AERO-MED, LLC
CA56125
In Commercial Distribution

  • 50885380200241 ()
  • 10885380200243 ()
CA56125

  • Urine specimen collection kit IVD
*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
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
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
C4 (Complement 4) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC635
Not in Commercial Distribution

  • 00817302020939 ()

  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 20 Milliliter
  • Total Volume: 8 Milliliter
CC635

  • Immunohistochemistry negative control (normal animal serum) IVD
C3 (Complement 3) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC634
Not in Commercial Distribution

  • 00817302020922 ()

  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 20 Milliliter
CC634

  • Immunohistochemistry negative control (normal animal serum) IVD
APO B (Apolipoprotein B) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC633
Not in Commercial Distribution

  • 00817302020915 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
APO B (Apolipoprotein B) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-633
In Commercial Distribution

  • 00817302020908 ()

  • Total Volume: 16 Milliliter
  • Total Volume: 46 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
AU-633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
APO B (Apolipoprotein B) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL633
Not in Commercial Distribution

  • 00817302020892 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 23 Milliliter
BL633

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
APO A1 (Apolipoprotein A1) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-632
Not in Commercial Distribution

  • 00817302020885 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 46 Milliliter
  • Total Volume: 16 Milliliter
AU-632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
APO A1 (Apolipoprotein A1) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL632
Not in Commercial Distribution

  • 00817302020878 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 23 Milliliter
BL632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
BUP (Buprenorphine) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT424
In Commercial Distribution

  • 00817302020861 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT424

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
BUP (Buprenorphine) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL424
In Commercial Distribution

  • 00817302020854 ()

  • Total Volume: 20 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
BL424

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
BUP (Buprenorphine) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST424
In Commercial Distribution

  • 00817302020823 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 63 Milliliter
  • Total Volume: 26 Milliliter
ST424

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
6-AM (6-Acetylmorphine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-425
In Commercial Distribution

  • 00817302020809 ()

  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 23 Milliliter
AU-425

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
6AM (6-Acetylmorphine) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST425
In Commercial Distribution

  • 00817302020793 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 63 Milliliter
  • Total Volume: 26 Milliliter
ST425

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
6AM (6-Acetylmorphine) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST325
In Commercial Distribution

  • 00817302020779 ()

  • Total Volume: 33 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 13 Milliliter
ST325

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
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