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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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Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre.
Schütz Dental GmbH
232022
In Commercial Distribution

  • ESDG2320221 ()


  • Dental composite resin
Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre.
Schütz Dental GmbH
232021
In Commercial Distribution

  • ESDG2320211 ()


  • Dental composite resin
Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre.
Schütz Dental GmbH
232020
In Commercial Distribution

  • ESDG2320201 ()


  • Dental composite resin
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)
VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.
Alafair Biosciences, Inc.
VTP2201
In Commercial Distribution

  • B454VTP22011 ()

  • Length: 2 Inch
  • Width: 2 Inch
  • Total Volume: 1 Milliliter
VTP2201

  • Tendon spacer
VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.
Alafair Biosciences, Inc.
VTP1201
In Commercial Distribution

  • B454VTP12011 ()

  • Length: 1 Inch
  • Width: 2 Inch
  • Total Volume: 1 Milliliter
VTP1201

  • Tendon spacer
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.013.0311
In Commercial Distribution

  • EKAV101303110 ()
T2M-S

  • Dental delivery system
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.012.8550
In Commercial Distribution

  • EKAV101285500 ()
TMC-L

  • Dental delivery system
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.012.8547
In Commercial Distribution

  • EKAV101285470 ()
TMM-S

  • Dental delivery system
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.012.8544
In Commercial Distribution

  • EKAV101285440 ()
PC-L

  • Dental delivery system
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