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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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Fetal Transducer Coro Toco Belt
AMERICAN IV PRODUCTS, INC.
FM10839
In Commercial Distribution

  • M745FM10839 ()

  • Length: 122.75 Inch
  • Height: 0.8 Inch
  • Outer Diameter: 2.75 Inch
FM10839

  • Tocodynamometer probe
Avalon Cableless Toco+ MP Transducer for use with Avalon CL Basestation 866074. Toco Transducer with Avalon Smart Pulse measurement and connector for maternal ECG, fetal ECG or IUP measurement.
Philips Medizin Systeme Böblingen GmbH
Avalon Cableless Toco+ MP Transducer
In Commercial Distribution

  • 00884838034235 ()
866075

  • Patient monitoring system module, multifunction
Toco MP Transducer including Toco and maternal Pulse Measurement
Philips Medizin Systeme Böblingen GmbH
Avalon TOCO MP Transducer
In Commercial Distribution

  • 00884838021471 ()
989803170601

  • Tocodynamometer probe
Avalon TOCO+ Transducer
Philips Medizin Systeme Böblingen GmbH
Avalon TOCO+ Transducer
In Commercial Distribution

  • 00884838002715 ()
989803143681

  • Patient monitoring system module, multifunction
The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.
Philips Medizin Systeme Böblingen GmbH
Avalon CL Fetal & Maternal Pod
In Commercial Distribution

  • 00884838068179 ()
866488

  • Tocodynamometer probe
QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.
QUANTIMETRIX CORPORATION
5210-12
In Commercial Distribution

  • M0515210120 ()
5210-12

  • Total protein IVD, reagent
The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-TRIHU-E01
Not in Commercial Distribution

  • B24225TRIHUE010 ()
25-TRIHU-E01

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
PTS Panels® CHOL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
1765
In Commercial Distribution

  • 00381931765016 ()
  • 10381931765013 ()
1765

  • Multiple lipid analyte IVD, kit, multiple technologies
OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
Nibec Co., Ltd.
CB-0110-050
In Commercial Distribution

  • 08809186549516 ()

  • Weight: .5 Gram


  • Dental bone matrix implant, animal-derived
OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
Nibec Co., Ltd.
CB-0110-025
In Commercial Distribution

  • 08809186549509 ()

  • Weight: .25 Gram


  • Dental bone matrix implant, animal-derived
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