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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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Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3806
In Commercial Distribution

  • 00840487100127 ()
3806

  • Endogenous RNA internal control reagent IVD
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600386-001
In Commercial Distribution

  • J00716003860011 ()
1600386-001

  • Dental power tool system handpiece, remotely-driven
SET of different CA & HP supplied for students.
Bien-Air Dental SA
1700794-001
In Commercial Distribution

  • J00717007941001 ()
1700794-001

  • Dental power tool system handpiece, remotely-driven
No Description
BIOMET MICROFIXATION, INC
91-6604-5PK
Not in Commercial Distribution

  • 00841036138233 ()
91-6604-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR)
In Commercial Distribution

  • B147PACETRAKPLUSENR0 ()


  • Electrocardiography telemetric monitoring system
Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Heartrak Smart Rev 5
In Commercial Distribution

  • B147HTSM50 ()


  • Electrocardiography telemetric monitoring system
5 VIALS
SEBIA
4795
In Commercial Distribution

  • 03607360047958 ()
4795

  • Carbohydrate deficient transferrin IVD, control
No Description
BIOMET MICROFIXATION, INC
91-6804-5PK
In Commercial Distribution

  • 00888233025317 ()
91-6804-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
BIOMET MICROFIXATION, INC
91-6604-5PK
In Commercial Distribution

  • 00888233012263 ()
91-6604-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
Berman Instruments LLC
EX723
In Commercial Distribution

  • 00810060722718 ()


  • Periodontal probe, reusable
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