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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
Baylis Médicale Cie Inc
PSZ-400-305
Not in Commercial Distribution

  • 00685447001744 ()


  • Suturing unit, single-use
The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1920
In Commercial Distribution

  • 00857377006124 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
CODAN Luer-Lock 20 ml, single use, syringe, sterile
Codan Medical ApS
62.7704
In Commercial Distribution

  • 05706225001123 ()
  • 05706225001147 ()


  • General-purpose syringe, single-use
Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 20” Filter 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.
70-0120
Not in Commercial Distribution

  • 20866318000378 ()
  • 00866318000374 ()
  • 10866318000371 ()


  • Microbial water purification filter, non-sterilizable
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
STANBIO LABORATORY, L.P.
1430-050
In Commercial Distribution

  • 00657498001356 ()
  • 00657498001363 ()
1430-050

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
BioHPP for2press - 20 g 5 pellets ds2 of 4 g each dentin-shade 2 5 Pieces
bredent GmbH & Co. KG
540F2P26
In Commercial Distribution

  • EBRE540F2P269 ()
  • EBRE540F2P260 ()
540F2P26

  • Dental bridge, polymer
No Description
Vista Dental
312202
In Commercial Distribution

  • 10818207024432 ()


  • Dental material injection cannula, single-use
No Description
NARVA Lichtquellen GmbH + Co KG.
FR79 T12 120W PH / BiPin
Not in Commercial Distribution

  • 84014501000980 ()
  • 54014501400987 ()
  • 04014501000984 ()
22010

  • Ultraviolet tanning device
No Description
Sarstedt Aktiengesellschaft & Co.KG
70.3021.100
In Commercial Distribution

  • 04038917904551 ()
  • 04038917904568 ()
70.3021.100

  • Pipette tip IVD
No Description
Sarstedt Aktiengesellschaft & Co.KG
70.3021.110
In Commercial Distribution

  • 04038917904520 ()
  • 04038917904537 ()
70.3021.110

  • Pipette tip IVD
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