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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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Ambroise - 08719327474433

Knee Orthosis (Gen.2)
Ambroise Holland B.V.
Genux 2
In Commercial Distribution

  • 08719327474433 ()


  • Custom-made lower-limb orthosis

IMMUNO-TROL - 03760170782034

Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid – Level 2 DNA* , Anti-ribosomal antigen Ribo , Anti-centromere antigen CENP-B , Anti-histidyl tRNA synthetase antigen Jo-1 , Anti-scleroderma antigen - 70 kDA Scl-70 .
THERADIAG SA
CONNECTIVE 2
In Commercial Distribution

  • 03760170782034 ()
HM 061US-2X05

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control

Two Striper - B868CFKT009691

Diamond Dental Bur
ABRASIVE TECHNOLOGY, INC.
SSIZE 2
In Commercial Distribution

  • B868CFKT009690 ()
  • B868CFKT009691 ()
CFKT00969

  • Diamond dental bur, reusable

STERISPINE LC - 03760219913047

No Description
SAFE ORTHOPAEDICS
KITANCLC 2
In Commercial Distribution

  • 03760219913047 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

NORDENT MANUFACTURING INC - 00840018629066

CARVER, HALF HOLLENBACK 3
NORDENT MANUFACTURING INC
CAH3-1/2
In Commercial Distribution

  • 00840018629066 ()


  • Dental restoration carver, amalgam, reusable

NORDENT MANUFACTURING INC - 00840018630024

CARVER, HALF HOLLENBACK #3S DL
NORDENT MANUFACTURING INC
CECAH3-1/2
In Commercial Distribution

  • 00840018630024 ()


  • Dental restoration carver, amalgam, reusable

NORDENT MANUFACTURING INC - 00840018629707

CARVER-AMALGAM HALF #3S - RND
NORDENT MANUFACTURING INC
RECAH3-1/2
In Commercial Distribution

  • 00840018629707 ()


  • Dental restoration carver, amalgam, reusable

Imagen Sensor BOOM size 2 - 08055060430450

DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430450 ()
IS039-DL

  • Dental digital imaging sensor, intraoral

I-View Silver size 2 - 08055060430436

DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430436 ()
IS035-DL

  • Dental digital imaging sensor, intraoral

Blu size 2 - 08055060430412

Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430412 ()

  • Width: 31.3 Millimeter
  • Length: 42.9 Millimeter
  • Height: 4.8 Millimeter
IS029-DL

  • Dental digital imaging sensor, intraoral
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