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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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5MM DIA., 32CM REUSABLE REPLACEMENT TIP PROTECTOR SLEEVE FOR BARD/DAVOL TYPE LAPAROSCOPIC ELECTRODES
ELMED INCORPORATED
52932-500
In Commercial Distribution

  • 00842180111479 ()
52932-500

  • Laparoscope system, reusable
Std Mediflex Tray for Arms, 22.7" x10.6" x 4.7" (56 X 26.5 X 11.75cm)
FLEXBAR MACHINE CORPORATION
69760
In Commercial Distribution

  • 00842102111730 ()


  • Instrument transport trolley system
Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 53-01
In Commercial Distribution

  • D801SP53011 ()
53-01

  • Dental pit/fissure sealant
Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. White.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 52-01
In Commercial Distribution

  • D801SP52011 ()
52-01

  • Dental pit/fissure sealant
Fits Schick CDR Elite Size 2 CustomFitted for Your Sensor UltraSoft Material Soft Seams
METREX RESEARCH, LLC
PSS3350C
In Commercial Distribution

  • D683PSS33501 ()
  • 00615375004814 ()
  • 00615375007570 ()


  • Cable/lead/sensor/probe cover, non-sterile
Fits Schick CDR Elite Size 1 CustomFitted for Your Sensor UltraSoft Material Soft Seams
METREX RESEARCH, LLC
PSS3340C
In Commercial Distribution

  • D683PSS33401 ()
  • 00615375004807 ()
  • 00615375007563 ()


  • Cable/lead/sensor/probe cover, non-sterile
Stainless Steel Endocavity Biopsy Starter Kit for Prosonic EC10R and Alpinion EN3-10 Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
7455
In Commercial Distribution

  • 00841912103713 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Body-orifice ultrasound imaging transducer cover, basic
  • Needle guide, reusable
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Perio, 4-7
In Commercial Distribution

  • 00647529003381 ()
  • 00647529003329 ()

  • Outer Diameter: 400 Micrometer
  • Length: 7 Millimeter
7400068

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Surgical, 4-4
In Commercial Distribution

  • 00647529003374 ()
  • 00647529003312 ()

  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
7400067

  • General/multiple surgical laser system beam guide, single-use, non-sterile
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