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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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AtriCure cryoICE Cryoablation System (CRYO3) - 00818354017892

cryoICE 10cm Cryoablation Probe
ATRICURE, INC.
CRYO3
In Commercial Distribution

  • 00818354017892 ()

  • Length: 10 Centimeter
A000925-6

  • General cryosurgical system, cryogen gas, mechanical

Anisakidae IgG ELISA - 07640158219805

The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection of Anisakidae antibodies in human serum samples.
Bordier affinity products S.A.
9800
In Commercial Distribution

  • 07640158219805 ()
9800

  • Anisakis species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Ascaris IgG ELISA - 07640158219256

The Ascaris ELISA test is a qualitative enzyme immunoassay for the detection of Ascaris in human serum samples.
Bordier affinity products S.A.
9250
In Commercial Distribution

  • 07640158219256 ()
9250

  • Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Aspergillus fumigatus IgG ELISA - 07640158216101

The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies in human serum samples.
Bordier affinity products S.A.
6100
In Commercial Distribution

  • 07640158216101 ()
6100

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ALLY II UPS (Uterine Positioning System) - 00888937026740

ALLY II UPS (Uterine Positioning System)
Coopersurgical, Inc.
AU-UPS2
In Commercial Distribution

  • 00888937026740 ()


  • Uterine manipulator, reusable

Adapter Drape (For RUMI II or Advincula Arch) - 00888937015812

Adapter Drape (For RUMI II or Advincula Arch)
Coopersurgical, Inc.
AU-AD
In Commercial Distribution

  • 20888937015816 ()
  • 00888937015812 ()


  • Medical equipment/instrument drape, single-use

APPLICATOR WRENCH (CT/MR FSD) - 00816389021075

No Description
Varian Medical Systems Deutschland GmbH
AL10715022
In Commercial Distribution

  • 00816389021075 ()
AL10715022

  • Vaginal brachytherapy system applicator, remote-afterloading

IMMY - 00816387020001

Aspergillus CF Antigen Dilute
Immuno-Mycologics, Inc.
A10150
In Commercial Distribution

  • 00816387020001 ()


  • Aspergillus fumigatus total antibody IVD, kit, complement fixation test (CFT)

Arthrex® - 00888867192676

Coupler, 90 Degree, C-MT
ARTHREX, INC.
AR-3210-0009
In Commercial Distribution

  • 00888867192676 ()
AR-3210-0009

  • Endoscope camera adaptor

X SERIES - 00812394026944

MAIN ASSY, X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, BRAZILIAN PORTUGUESE, REFURB
Zoll Medical Corporation
620-2220011-24-66
In Commercial Distribution

  • 00812394026944 ()


  • Rechargeable professional automated external defibrillator
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