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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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The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct bilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0026
In Commercial Distribution

  • EABA40000261 ()
  • EABA40000260 ()
400-0026

  • Total alkaline phosphatase (ALP) IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Conjugated (direct) bilirubin IVD, reagent
  • Albumin IVD, reagent
  • Total protein IVD, reagent
  • Total bilirubin IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
CAMERA S900 NTSC SANS SUPPORT
In Commercial Distribution

  • M430S90000041 ()
S_900_0004

  • Diagnostic-imaging multiformat camera
"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
CAMERA S900 NTSC SOPROLIFE
In Commercial Distribution

  • M430S90000021 ()
S_900_0002

  • Diagnostic-imaging multiformat camera
The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.
BIOMERIEUX SA
500011
In Commercial Distribution

  • B0745000110 ()
500011

  • Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122049663SAM1 ()
  • M71389122049663SAM0 ()

  • Total Volume: 3 Milliliter
FID185704

  • Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
89122-0496-63
Not in Commercial Distribution

  • M71389122049663A16 ()
  • M71389122049663 ()

  • Total Volume: 3 Milliliter
89122-0496-63

  • Synovial fluid supplementation medium
The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin in samples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound from free is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzyme substrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measured absorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration of albumin in the urine is determined from a calibration curve.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
24-MABHU-E01
Not in Commercial Distribution

  • B24224MABHUE010 ()
24-MABHU-E01

  • Albumin IVD, kit, enzyme immunoassay (EIA)
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.
FIDIA FARMACEUTICI SPA
89122-0724-20
In Commercial Distribution

  • M713891220724200 ()
89122-0724-20

  • Synovial fluid supplementation medium
Rescuer disposable CPR facemask with oxygen inlet, head strap, one way valve in a hard shell case
B.L.S. Systems Limited
2025-HS-CC
In Commercial Distribution

  • B0022025HSCC0 ()
  • B0022025HSCC8 ()
2025-HS-CC

  • Cardiopulmonary resuscitation mask, single-use
3.8mm 10' Autoclavable Fiber Light Cable, Light Source Type: Olympus, Scope Type: ACMI, Small Snap In Fitting
Surgical Direct, Inc.
SD6233115
In Commercial Distribution

  • B382SD62331150 ()

  • Length: 10 Feet
  • Outer Diameter: 3.8 Millimeter
SD6233115

  • Fibreoptic light cable
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