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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CLC6410 Clinical Chemistry Analyzer with ISE
CAROLINA LIQUID CHEMISTRIES CORPORATION
CLC6410
In Commercial Distribution

  • 00817302023121 ()

  • Height: 46 Inch
  • Width: 76 Inch
  • Depth: 49 Inch
  • CLC6410 Clinical Chemistry Analyzer with ISE
CLC6410i

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
  • Multi-modality clinical specimen analysis system IVD
TOTAL BENZODIAZEPINE, 3 X 335 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST441
In Commercial Distribution

  • 00817302021967 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 189 Milliliter
ST441

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT412
In Commercial Distribution

  • 00817302021813 ()

  • Total Volume: 29 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 59 Milliliter
DT412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
THC (Cannabinoid)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-410A
In Commercial Distribution

  • 00817302021745 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
TP (Total Protein) 2 X 300 TESTS
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC217
In Commercial Distribution

  • 00817302020755 ()

  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 101 Milliliter
CC217

  • Total protein IVD, kit, spectrophotometry
BUN (Blood Urea Nitrogen) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC252
In Commercial Distribution

  • 00817302020380 ()

  • Total Volume: 15 Milliliter
  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 102 Milliliter
CC252

  • Urea IVD, kit, spectrophotometry
Phosphorus (PHOS)
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC218
In Commercial Distribution

  • 00817302024272 ()

  • Total Volume: 83 Milliliter
  • Total Volume: 12 Milliliter
  • Kit contains 2 cartridges
CC218

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
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
No Description
BIOTECHNOLOGY INSTITUTE SL
RSMA
In Commercial Distribution

  • 08435389829119 ()


  • Dental implant suprastructure, temporary, preformed, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
RSMU
In Commercial Distribution

  • 08435389829126 ()


  • Dental implant suprastructure, temporary, preformed, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
RSME
In Commercial Distribution

  • 08435389829102 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Precision Flow Oxygen Assist Module, Nellcor UKIT South Africa
VAPOTHERM, INC.
OAM-NEL-UKIT-ZA
In Commercial Distribution

  • 00841737104315 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, Masimo UKIT South Africa
VAPOTHERM, INC.
OAM-MAS-UKIT-ZA
In Commercial Distribution

  • 00841737104308 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Personal Use Kit OC-Auto, for KPS South bay (HBRCTY)
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS SB
In Commercial Distribution

  • 00816917020402 ()


  • Faecal occult blood IVD, reagent
Blood Culture Collection Kit, Baptist Medical Center South Only
AERO-MED, LLC
CA15850
Not in Commercial Distribution

  • 50885380164130 ()
  • 10885380164132 ()
CA15850

  • Phlebotomy kit
MTS L/H KIT 1 -SOUTH AUSTIN HOSP PG
MEDLINE INDUSTRIES, INC.
60183292
In Commercial Distribution

  • 20193489050025 ()
  • 10193489050028 ()
60183292

  • Angiography kit
Personal Use Kit OC-Auto, Custom Kit for CPL South East
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-CPLSE
In Commercial Distribution

  • 00816917023090 ()


  • Faecal occult blood IVD, reagent
SINGLE LINE KIT WITH 03ML DEVICE FOR SOUTH SHORE HOSP
ICU MEDICAL, INC.
46099-05
In Commercial Distribution

  • 10840619045279 ()
  • 00840619045272 ()
46099-05

  • In-line arterial blood sampling set
1st Tier 4mm x 32G pen needles
OWEN MUMFORD USA INCORPORATED
AN 3540SPW
In Commercial Distribution

  • 00761059541851 ()
  • 00761059540854 ()
  • 00761059542858 ()
  • 00384703540002 ()

  • Length: 4 Millimeter
  • Needle Gauge: 32 Gauge


  • Autoinjector needle
1st Tier 8mm x 31G pen needles
OWEN MUMFORD USA INCORPORATED
AN 3530SPW
In Commercial Distribution

  • 00761059531852 ()
  • 00761059530855 ()
  • 00761059532859 ()
  • 00384703530003 ()

  • Length: 8 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
1st Tier 6mm x 31G pen needles
OWEN MUMFORD USA INCORPORATED
AN 3590SPW
In Commercial Distribution

  • 00761059591856 ()
  • 00761059590859 ()
  • 00761059592853 ()
  • 00384703590007 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
1st Tier 5mm x 31g pen needles
OWEN MUMFORD USA INCORPORATED
AN 3550SPW
In Commercial Distribution

  • 00761059551850 ()
  • 00761059550853 ()
  • 00761059552857 ()
  • 00384703530003 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CY010, 5mmX35cm EPIX® LAPA DISSECT, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2656
In Commercial Distribution

  • 30607915133529 ()


  • Rigid endoscopic grasping forceps, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
5ply;SZ 1,2 Lngth 10-14
Alps South, LLC
CB5MDSH2
In Commercial Distribution

  • 00713980000280 ()


  • Stump sock
3ply;SZ 1,2 Lngth 10-14
Alps South, LLC
CB3MDSH2
In Commercial Distribution

  • 00713980000273 ()


  • Stump sock
6ply;SZ 1,2 Lngth 8-12
Alps South, LLC
CB6MDXS2
In Commercial Distribution

  • 00713980000259 ()


  • Stump sock
1ply;SZ 1,2 Lngth 8-12
Alps South, LLC
CB1MDXS2
In Commercial Distribution

  • 00713980000235 ()


  • Stump sock
3ply;SZ B,0 Lngth 22-26
Alps South, LLC
CB3NALG2
In Commercial Distribution

  • 00713980000204 ()


  • Stump sock
6ply;SZ B,0 Lngth 16-20
Alps South, LLC
CB6NARG2
In Commercial Distribution

  • 00713980000181 ()


  • Stump sock
5ply;SZ B,0 Lngth 16-20
Alps South, LLC
CB5NARG2
In Commercial Distribution

  • 00713980000174 ()


  • Stump sock
3ply;SZ B,0 Lngth 16-20
Alps South, LLC
CB3NARG2
In Commercial Distribution

  • 00713980000167 ()


  • Stump sock
1ply;SZ B,0 Lngth 16-20
Alps South, LLC
CB1NARG2
In Commercial Distribution

  • 00713980000150 ()


  • Stump sock
6ply;SZ B,0 Lngth 10-14
Alps South, LLC
CB6NASH2
In Commercial Distribution

  • 00713980000143 ()


  • Stump sock
5ply;SZ B,0 Lngth 10-14
Alps South, LLC
CB5NASH2
In Commercial Distribution

  • 00713980000136 ()


  • Stump sock
1ply;SZ B,0 Lngth 10-14
Alps South, LLC
CB1NASH2
In Commercial Distribution

  • 00713980000112 ()


  • Stump sock
5ply;SZ B,0 Lngth 8-12
Alps South, LLC
CB5NAXS2
In Commercial Distribution

  • 00713980000099 ()


  • Stump sock
1PLY w/Sewn Hole SZ 1, 2 LNGTH 8-12
Alps South, LLC
CB1HMXS2
In Commercial Distribution

  • 00713980000075 ()


  • Stump sock
6ply;SZ 1,2 Lngth 22-26
Alps South, LLC
CB6MDLG2
In Commercial Distribution

  • 00713980000051 ()


  • Stump sock
3ply;SZ 1,2 Lngth 8-12
Alps South, LLC
CB3MDXS2
In Commercial Distribution

  • 00713980000037 ()


  • Stump sock
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