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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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BONECUTTER OSTEOTOME HANDSET
ORTHOFIX SRL
1
In Commercial Distribution

  • 18056099649995 ()
OHB300/2

  • Hard/soft-tissue ultrasonic surgical system
CEMENT REMOVAL HANDSET
ORTHOFIX SRL
1
In Commercial Distribution

  • 18056099649988 ()
OH300/2

  • Hard/soft-tissue ultrasonic surgical system
No Description
HAPAD INC
2 1/2" x 1/2"
In Commercial Distribution

  • 00082147001058 ()
HP2-1

  • Orthotic insole, prefabricated, non-antimicrobial
Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 180 antibodies in human serum. The MESACUP BP180 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
48 wells
In Commercial Distribution

  • 04987506015959 ()
7695US

  • Bullous pemphigoid antigen 2 (BPAG2) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07108133162
In Commercial Distribution

  • 07613336183182 ()
07108133162

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
No Description
Roche Diagnostics GmbH
09366989190
In Commercial Distribution

  • 07613336183014 ()
09366989190

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
No Description
Bion Enterprises, Ltd.
RG-M7612-D
Not in Commercial Distribution

  • B110RGM7612D0 ()
RG-M7612-D

  • Bullous pemphigoid antigen 2 (BPAG2) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
310621
In Commercial Distribution

  • 08056771600118 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0902
In Commercial Distribution

  • 10816101022370 ()
EL0902

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, reagent
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