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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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The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DGH 1006
In Commercial Distribution

  • 00857377006209 ()


  • Ophthalmic ultrasound imaging transducer
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
NORTH EAST SCIENTIFIC INC
R-410-154
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral
The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
HISTOLOGICS, LLC
SFT-4200
In Commercial Distribution

  • 00860275000361 ()
  • 10860275000368 ()


  • Wound debridement tool
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 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
Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-ATO1
In Commercial Distribution

  • 05060652910039 ()
SWF-ATO1

  • Intraoperative gamma radiation detection system probe cover
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL101
In Commercial Distribution

  • 60849771050416 ()
  • 10849771050411 ()
  • 00849771050414 ()
  • 00849771037873 ()
EL101

  • Electrosurgical electrode lubricant
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL-101
Not in Commercial Distribution

  • 10849771037870 ()
  • 00849771037873 ()

  • Total Volume: 4 Milliliter
EL101

  • Electrosurgical electrode lubricant
NetCom Client is an application programming interface (API) that is intended to allow data transfer to/from the Pegasus software.
NEURALYNX, INC.
3.1.0
In Commercial Distribution

  • 00850011306673 ()
36-0301-0004

  • Electroencephalographic monitoring system
The device FlexPointer is a navigation probe for image guided surgery. The device is component to the Cube4D Navigation system.
Fiagon GmbH
E012002
In Commercial Distribution

E012002

  • Multi-purpose stereotactic surgery system
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
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
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
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
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
The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
GENERAL MEDICAL MERATE SPA
X-RAY R&F REMOTE SYSTEM OPERA SWING
In Commercial Distribution

  • 08054890480000 ()

  • Weight: 1120 Kilogram


  • Stationary general-purpose fluoroscopic x-ray system, digital
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part B.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSB
In Commercial Distribution

  • D798BLSB0 ()
BLSB

  • Orthodontic bracket adhesive
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Compact
In Commercial Distribution

  • 08800018421000 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 with rotation
In Commercial Distribution

  • 08800018420706 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 86 Basic
In Commercial Distribution

  • 08800018422502 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 without rotation
In Commercial Distribution

  • 08800018421406 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Basic
In Commercial Distribution

  • 08800018421307 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Samsung
In Commercial Distribution

  • 08800018421109 ()


  • X-ray film cassette holder
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.
EL.EN. SPA
M053Z1
In Commercial Distribution

  • 08057017760474 ()
M053Z1

  • General/multiple surgical solid-state laser system
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
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

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


  • Atherectomy laser system beam guide-catheter, peripheral
The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-014R
Not in Commercial Distribution

  • NRP014 ()

  • Catheter Working Length: 150 Centimeter
  • Catheter Gauge: 3.5 French
  • Lumen/Inner Diameter: .014 Inch
R-014R

  • Intravascular ultrasound imaging catheter, reprocessed
Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB22910 ()
BSB 2291

  • Uroplakin IVD, antibody
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