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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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Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit is intended for the in vitro qualitative determination of porphobilinogen (PBG) in urine to aid in the primary screening for acute porphyria. For Professional Use only.
TECO DIAGNOSTICS
URS-PBG-1
In Commercial Distribution

  • 10673486001006 ()
URS-PBG-1

  • Porphobilinogen IVD, reagent
The Advanced Instruments 3250 Single-Sample Osmometer is designed for routine osmolality measurement in pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-4000 mOsm.
ADVANCED INSTRUMENTS, INC.
3250
In Commercial Distribution

  • 00816068020870 ()
3250

  • Osmometric analyser IVD, semi-automated
The Fiske 210 Single-Sample Micro-Osmometer is designed for routine osmolality measurement in clinical, pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-2000 mOsm.
ADVANCED INSTRUMENTS, INC.
210
In Commercial Distribution

  • 00816068020863 ()
210

  • Osmometric analyser IVD, semi-automated
Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022588 ()
LABSCNXS4

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The C.A.T.S (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Fresenius Kabi AG
9005081
In Commercial Distribution

  • 04086000860031 ()
9005081

  • Red blood cell-recovery autotransfusion system
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
DiaDent Group International
DIA-ROOT BIO Sealer 0.5g
In Commercial Distribution

  • 08806383577946 ()
1003-702

  • Endodontic filling/sealing material
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
DiaDent Group International
DIA-ROOT BIO Sealer 2.0g
In Commercial Distribution

  • 08806383565790 ()
1003-701

  • Endodontic filling/sealing material
VOCO Profluorid Varnish is a fluoride containing dental varnish for surface application to enamel and dentin. 1 ml VOCO Profluorid Varnish contains 50 mg of sodium fluoride equivalent to 22.6 mg of fluoride.
VOCO GmbH
1270
In Commercial Distribution

  • E22112701 ()
  • E22112700 ()
1270

  • Dental coating, tooth-desensitizing
VOCO Profluorid Varnish is a fluoride containing dental varnish for surface application to enamel and dentin. 1 ml VOCO Profluorid Varnish contains 50 mg of sodium fluoride equivalent to 22.6 mg of fluoride.
VOCO GmbH
1267
In Commercial Distribution

  • E22112671 ()
1267

  • Dental coating, tooth-desensitizing
The Integra Total Foot System mini calcaneus plate is a low profile, less invasive plate fixation for calcaneal fracture procedures. It reduces the need for a large calcaneal flap incision in most cases.
Ascension Orthopedics, Inc.
2805006
Not in Commercial Distribution

  • 10381780118299 ()
  • M26828050061 ()

  • 46.69mm L x 16.67mm W x 1.3mm H
2805006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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