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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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E/P Pack - 04033817900849

No Description
LivaNova Deutschland GmbH
Battery Discharger
In Commercial Distribution

  • 04033817900849 ()


  • Cardiopulmonary bypass system, roller type

E/P Pack - 04033817900832

No Description
LivaNova Deutschland GmbH
S5
In Commercial Distribution

  • 04033817900832 ()


  • Cardiopulmonary bypass system, roller type

Needle guide E - 04547410181784

This guide is used for the VAB type needle.
FUJIFILM CORPORATION
NEEDLE GUIDE EN E
In Commercial Distribution

  • 04547410181784 ()


  • Stationary mammographic x-ray system, digital

Needle holder E - 04547410181777

Holder to fix the Biopsy Needle
FUJIFILM CORPORATION
NEEDLE HOLDER EN E
In Commercial Distribution

  • 04547410181777 ()


  • Stationary mammographic x-ray system, digital

E. HISTOLYTICA II - 00857031002349

The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test.
TECHLAB, INC.
T5017
In Commercial Distribution

  • 00857031002349 ()


  • Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

E. HISTOLYTICA II - 00857031002011

The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test.
TECHLAB, INC.
30404
In Commercial Distribution

  • 00857031002011 ()


  • Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

Cranex Novus e - 06430035872428

No Description
PaloDEx Group Oy
CRA-2
Not in Commercial Distribution

  • 06430035872428 ()
900651

  • Stationary panoramic/tomographic dental x-ray system, digital

NOVAE E TH - 03662200005369

NOVAE Dual Mobility Acetabular Cup - NOVAE E TH metal-back cementless NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium)
SOC ETUDES RECHERCHES FABRICATION
NOVAE E 71 TH
In Commercial Distribution

  • 03662200005369 ()


  • Acetabular shell

NOVAE E TH - 03662200005345

NOVAE Dual Mobility Acetabular Cup - NOVAE E TH metal-back cementless NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium)
SOC ETUDES RECHERCHES FABRICATION
NOVAE E 67 TH
In Commercial Distribution

  • 03662200005345 ()


  • Acetabular shell

NOVAE E TH - 03662200005376

NOVAE Dual Mobility Acetabular Cup - NOVAE E TH metal-back cementless NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium)
SOC ETUDES RECHERCHES FABRICATION
NOVAE E 73 TH
In Commercial Distribution

  • 03662200005376 ()


  • Acetabular shell
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