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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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Bausch + Lomb - 00757770414130

SILICONE TUBE .020"x.037"x10FT
Bausch & Lomb Incorporated
N5941 2
In Commercial Distribution

  • 00757770414130 ()
N5941 2

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770413683

SPEC GRUBER OVAL HEAVY LONG #2
Bausch & Lomb Incorporated
N0266 2
In Commercial Distribution

  • 00757770413683 ()
N0266 2

  • Ear speculum, reusable

Bausch + Lomb - 00757770407842

FCP BP 4-1/2IN CUSHING F/S2050
Bausch & Lomb Incorporated
S2050 2
In Commercial Distribution

  • 00757770407842 ()
S2050 2

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

HEp-2000® Fluorescent ANA-Ro Test System - M7490202521

ANA Centromere Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2025 (2)
In Commercial Distribution

  • M7490202521 ()
2025 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

HEp-2000® Fluorescent ANA-Ro Test System - M7490202321

ANA Nucleolar Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2023 (2)
In Commercial Distribution

  • M7490202321 ()
2023 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

HEp-2000® Fluorescent ANA-Ro Test System - M7490202221

ANA Speckled Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2022 (2)
In Commercial Distribution

  • M7490202221 ()
2022 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control

Tryptic Soy Broth 15g/L 2L in 20L bag - 05407010127195

No Description
Lonza Verviers
BE26-279P20/2
In Commercial Distribution

  • 05407010127195 ()
BE26-279P20/2

  • Differential/selective broth culture medium IVD

ANCA Test System - M7491003121

ANCA Negative Control - 2 x 1 ml.
IMMUNO CONCEPTS INC
10031 (2)
In Commercial Distribution

  • M7491003121 ()
10031 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100261221

cANCA Titratable Control - PR3 2 x 0.25ml
IMMUNO CONCEPTS INC
10026-12 (2)
In Commercial Distribution

  • M749100261221 ()
10026-12 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

ANCA Test System - M749100261121

pANCA Titratable Control - MPO - 2 x 0.25ml
IMMUNO CONCEPTS INC
10026-11 (2)
In Commercial Distribution

  • M749100261121 ()
10026-11 (2)

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control
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