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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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No Description
Hasa Optix
HA-SET010
In Commercial Distribution

  • 05404027446608 ()
  • 05404027444581 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 10
In Commercial Distribution

  • 09010522000113 ()
  • 09010522001257 ()
100370

  • Dental implant stability resonance frequency analysis peg
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00010
In Commercial Distribution

  • 00858395006424 ()
  • 00858395006158 ()
GW-MOL-SP10

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00010
In Commercial Distribution

  • 00858395006080 ()
  • 00858395006158 ()
GW-MOL-SP10

  • Dental delivery system instrument unit, electric
t:flex Insulin Pump Cartridges 10 pack
Tandem Diabetes Care, Inc.
004695
In Commercial Distribution

  • 00852162004392 ()
  • 00852162004774 ()

  • Total Volume: 4.8 Milliliter


  • Ambulatory insulin infusion pump reservoir
t:slim Cartridge 10 Pack
Tandem Diabetes Care, Inc.
003380
In Commercial Distribution

  • 00852162004347 ()
  • 00852162004767 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir
CODAN Luer-Lock 10 ml, single use, syringe, sterile
Codan Medical ApS
62.6706
In Commercial Distribution

  • 05706225000942 ()
  • 05706225000966 ()


  • General-purpose syringe, single-use
Ten units of disposable corneal contact lens electrode used for measurement and recording of full field electroretinography (ERG) signals.
Retmap, Inc.
RMH 23-01
In Commercial Distribution

  • 00860012396115 ()
  • 00860012396108 ()


  • Electroretinograph electrode
No Description
C4 IMAGING, LLC
F-01-03-0115
Not in Commercial Distribution

  • 00863593000273 ()


  • Radiological image marker, implantable
Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110
Not in Commercial Distribution

  • 20866318000354 ()
  • 10866318000357 ()
  • 00866318000350 ()


  • Microbial water purification filter, non-sterilizable
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