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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
LivaNova Deutschland GmbH
Battery Discharger
In Commercial Distribution

  • 04033817900849 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
S5
In Commercial Distribution

  • 04033817900832 ()


  • Cardiopulmonary bypass system, roller type
No Description
B& L Biotech, inc.
JT2FE
In Commercial Distribution

  • 08800019110392 ()


  • Dental ultrasonic surgical system
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
Holder to fix the Biopsy Needle
FUJIFILM CORPORATION
NEEDLE HOLDER EN E
In Commercial Distribution

  • 04547410181777 ()


  • Stationary mammographic x-ray system, digital
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5300200
In Commercial Distribution

  • D82853002000 ()


  • Orthodontic palate expander/teeth aligner, bonded
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)
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)
No Description
PaloDEx Group Oy
CRA-2
Not in Commercial Distribution

  • 06430035872428 ()
900651

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