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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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Cystine Lactose Electrolyte Deficient (CLED) Agar - 00860003684658

Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684658 ()
NCM0034B

  • Differential/selective agar culture medium IVD

Cystine Lactose Electrolyte Deficient (CLED) Agar - 00860003684641

Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684641 ()
NCM0034A

  • Differential/selective agar culture medium IVD

Zemits Leger - 00860010841105

Large-area electric massager
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860010841105 ()
2003181

  • Freestanding electric massager

Zemits EndoLuxx - 00860009982499

No Description
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860009982499 ()
113622

  • Freestanding electric massager

Zemits Abigon Pro - 00860009982475

No Description
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860009982475 ()
114921

  • Multi-modality skin surface treatment system

Zemits FrioLift - 00860009982444

No Description
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860009982444 ()
104522

  • Multi-modality skin surface treatment system

Zemits Bionexis Lite - 00860009982482

No Description
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860009982482 ()
10001

  • Multi-modality skin surface treatment system

OLINDA/EXM - 00859873006035

The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Hermes Medical Solutions AB
2
In Commercial Distribution

  • 00859873006035 ()


  • Nuclear medicine system workstation

Inion GTR™ Instruments - 06438408009907

Drill bit
Inion Oy
2
In Commercial Distribution

  • 06438408009907 ()
INS-9051

  • Fluted surgical drill bit, reusable

Inion FreedomScrew instruments - 06438408007934

Depth gauge for Ø2.7/3.5 mm screws (INS-9091)
Inion Oy
2
In Commercial Distribution

  • M224IFS904120 ()
  • 06438408007934 ()
IFS-9041

  • Surgical depth gauge, reusable
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