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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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NXSTAGE MEDICAL, INC.
NX1000-10-E
In Commercial Distribution

  • M535NX100010E0 ()


  • Haemodialysis system, institutional/home-use
Matrix sleeve with fixing screw 1.8 mm Ø 2 Pieces each 4 Pieces
bredent GmbH & Co. KG
43007298
In Commercial Distribution

  • EBRE430072989 ()
  • EBRE430072980 ()
  • EBRE430072988 ()

  • Length: 5.3 Millimeter
  • Outer Diameter: 3.2 Millimeter
43007298

  • Screw endosteal dental implant, two-piece
Matrix sleeve with fixing screw 1.0 mm Ø 2 Pieces each 4 Pieces
bredent GmbH & Co. KG
43007296
In Commercial Distribution

  • EBRE430072969 ()
  • EBRE430072960 ()
  • EBRE430072968 ()

  • Length: 5.3 Millimeter
  • Outer Diameter: 2.8 Millimeter
43007296

  • Screw endosteal dental implant, two-piece
40cm Cannula with Guide
ATRICURE, INC.
CSK-6140
In Commercial Distribution

  • 00818354015393 ()

  • Length: 40 Centimeter


  • Cardiac radio-frequency ablation system generator
30cm Cannula with Guide
ATRICURE, INC.
CSK-6130
In Commercial Distribution

  • 00818354015379 ()

  • Length: 30 Centimeter


  • Cardiac radio-frequency ablation system generator
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
ALLWIN MEDICAL DEVICES, INC.
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
In Commercial Distribution

  • 10819374021750 ()
  • 00819374021753 ()
TPEB-ETC-STY

  • Assisted reproduction transfer catheter/set
110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XSFL
Not in Commercial Distribution

  • 10818666020280 ()
  • 00818666020283 ()


  • Electric infusion pump administration set, single-use
Apollo Medial with needles
MEDLINE INDUSTRIES, INC.
27-11145
In Commercial Distribution

  • 00818614021355 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
BAXTER HEALTHCARE CORPORATION
5C4466P
In Commercial Distribution

  • 50085412007699 ()
  • 00085412007694 ()
5C4466P

  • Peritoneal dialysis system tubing set
HTF Medium with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90125-500mL
In Commercial Distribution

  • 00893727002910 ()

  • Total Volume: 500 Milliliter
90125

  • IVF medium
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