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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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Hy-Pro Lucitone® - D0019844100

Fibered Light. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Light (684406) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019844100 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

Hy-Pro Lucitone® - D0019841660

Fibered Dark. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Dark (684175) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019841660 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

DENTSPLY® Repair Material - D0019800540

Light Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800540 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin

DENTSPLY® Repair Material - D0019800530

Pink Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800530 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin

Lucitone® - D0016843050

This is sold as part of the 11-Unit Packages for Lucitone 199 and Hy-Pro Lucitone. It is not sold separately.
Dentsply International Inc.
Liquid
In Commercial Distribution

  • D0016843050 ()

  • Total Volume: 120 Milliliter


  • Dental appliance fabrication material, resin

Embrella(TM) Endoscopic Distal Attachment - 06932503560825

The endoscope with a diameter of 12.8-14.5mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
Micro-Tech (Nanjing) Co., Ltd.
EM-S-01
In Commercial Distribution

  • 16932503560822 ()
  • 06932503560825 ()
  • 26932503560829 ()


  • Colonoscope distal anchoring cuff

Embrella(TM) Endoscopic Distal Attachment - 06932503560818

The endoscope with a diameter of 11.5-13mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
Micro-Tech (Nanjing) Co., Ltd.
EM-S-02
In Commercial Distribution

  • 16932503560815 ()
  • 06932503560818 ()
  • 26932503560812 ()


  • Colonoscope distal anchoring cuff

Metapex(2 Syringe) - 08806387892014

Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 2 Syringe(2.2g)
Meta Biomed Co., Ltd.
9201
In Commercial Distribution

  • 08806387892014 ()


  • Endodontic temporary cement

Metapex(1 Syringe) - 08806387892007

Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)
Meta Biomed Co., Ltd.
9200
In Commercial Distribution

  • 08806387892007 ()


  • Endodontic temporary cement

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral
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