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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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Ionto Plus Medium 2.5 cc - 00853904006018

Iontophoresis Drug Delivery Electrodes
COMPASS HEALTH BRANDS CORP.
201-438
In Commercial Distribution

  • 00853904006018 ()


  • Drug-delivery iontophoresis patch

Ionto Plus Butterfly 2.0 cc - 00853904006001

Iontophoresis Drug Delivery Electrodes
COMPASS HEALTH BRANDS CORP.
201-439
In Commercial Distribution

  • 00853904006001 ()


  • Drug-delivery iontophoresis patch

5-Pack, 100 cc Syringe, Luer-locking - 00851607003518

Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system

INSERT CC 26 X 60 - M209118010

No Description
BIOPRO, INC.
11801
In Commercial Distribution

  • M209118010 ()


  • Polyethylene patella prosthesis

INSERT CC 26 X 58 - M209118000

No Description
BIOPRO, INC.
11800
In Commercial Distribution

  • M209118000 ()


  • Polyethylene patella prosthesis

INSERT CC 26 X 55 - M209117990

No Description
BIOPRO, INC.
11799
In Commercial Distribution

  • M209117990 ()


  • Polyethylene patella prosthesis

INSERT CC 26 X 53 - M209117980

No Description
BIOPRO, INC.
11798
In Commercial Distribution

  • M209117980 ()


  • Polyethylene patella prosthesis

INSERT CC 26 X 50 - M209117970

No Description
BIOPRO, INC.
11797
In Commercial Distribution

  • M209117970 ()


  • Polyethylene patella prosthesis

INSERT CC 26 X 48 - M209117960

No Description
BIOPRO, INC.
11796
In Commercial Distribution

  • M209117960 ()


  • Polyethylene patella prosthesis

TRUWAVE X 3 (3 CC) - 07460691952829

PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXMK1140
In Commercial Distribution

  • 57460691952824 ()
  • 07460691952829 ()

  • Total Volume: 3.0000 Milliliter
PXMK1140

  • Invasive-pressure external transducer, single-use
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