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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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A non-sterile, long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part.
Greenguard
6253
In Commercial Distribution

  • 50347682625332 ()
  • 00347682625337 ()
6253

  • Waterproof skin adhesive tape
AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Dentsply De Trey GmbH
60620101
In Commercial Distribution

  • D010606201011 ()
  • D010606201010 ()

  • Weight: 8 Gram
  • Paste
  • Powder
  • Weight: 10 Gram
60620101

  • Endodontic filling/sealing material
This is a plastic box outside a drug bag less than or equal to 100ml.
INFUTRONIX LLC
Nimbus Hard Shell 100ml
In Commercial Distribution

  • 00817170020154 ()
  • 20817170020158 ()
  • 10817170020151 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic
3 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-202
In Commercial Distribution

  • 00853818007323 ()
PB-202

  • Medical device USB cable
6 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-200
In Commercial Distribution

  • 00853818007187 ()


  • Medical device USB cable
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02
In Commercial Distribution

  • D801SP65021 ()
65-02

  • Dentine adhesive
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS-1000
In Commercial Distribution

  • 06970136030216 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS2000A
In Commercial Distribution

  • 06970136030100 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
DOUBLE ACTION WIRE CUTTER TC A
SURGIX MEDICAL LLC
G2G35737
In Commercial Distribution


  • Length: 220 Millimeter
  • Tip/Jaw Length 26 mm
G2G35737

  • Wire cutter
A device intended to flush endoscopes.
Wassenburg Medical, Inc.
83-S8
Not in Commercial Distribution

  • PPS83S8 ()


  • Endoscope washer/disinfector
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