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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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POLARIS 5.5 SPINAL SYSTEM - 00888480212225

No Description
BIOMET SPINE LLC
2000-5548
In Commercial Distribution

  • 00888480212225 ()

  • ANGLED BLADE HOOK, SMALL (6MM)
2000-5548

  • Bone-screw internal spinal fixation system, non-sterile

Aquaporin-4 Auto-Antibody (AQP4Ab) - B126KR82000

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT - B126KR77100

An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
KRONUS, INC.
KR7710
In Commercial Distribution

  • B126KR77100 ()
KR7710

  • Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)

KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT - B126KR67100

An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
KRONUS, INC.
KR6710
In Commercial Distribution

  • B126KR67100 ()
KR6710

  • Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62750

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62700

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

Bio-Med Devices, Inc. - 00813841021239

Air / Oxygen Blender with 3 ports
BIO-MED DEVICES, INC.
2004B
In Commercial Distribution

  • 00813841021239 ()
2004B

  • Oxygen/air breathing gas mixer, hospital

Bio-Med Devices, Inc. - 00813841021215

Air / Oxygen Blender low flow switching
BIO-MED DEVICES, INC.
2003KB
In Commercial Distribution

  • 00813841021215 ()
2003KB

  • Oxygen/air breathing gas mixer, hospital

Bio-Med Devices, Inc. - 00813841020393

Air / Oxygen Blender low flow MR-conditional
BIO-MED DEVICES, INC.
2003M
In Commercial Distribution

  • 00813841020393 ()
2003M

  • Oxygen/air breathing gas mixer, hospital

Bio-Med Devices, Inc. - 00813841020379

Air / Oxygen Blender low flow for CV
BIO-MED DEVICES, INC.
2003KC
In Commercial Distribution

  • 00813841020379 ()
2003KC

  • Oxygen/air breathing gas mixer, hospital
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