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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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Integra® Miltex® - 10381780470588

Integra® Miltex® Carbide Burs, RA, 1/2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DRA1/2
In Commercial Distribution

  • H834DRA121 ()
  • 10381780470588 ()
  • 00381780470581 ()
DRA1/2

  • Carbide dental bur, single-use

Integra® Miltex® - 10381780470366

Integra® Miltex® Carbide Burs, HP, 33-1/2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DHP331/2
In Commercial Distribution

  • H834DHP33121 ()
  • 10381780470366 ()
  • 00381780470369 ()
DHP331/2

  • Carbide dental bur, single-use

Integra® Miltex® - 10381780469537

Integra® Miltex® Carbide Burs, FG, 33-1/2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DFG331/2
In Commercial Distribution

  • H834DFG33121 ()
  • 10381780469537 ()
  • 00381780469530 ()
DFG331/2

  • Carbide dental bur, single-use

N/A - B582801510120

ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
GEORGE TIEMANN & CO.
8015101/2
In Commercial Distribution

  • B582801510120 ()
8015101/2

  • Bone lever/elevator, reusable

Ovultell® - 00817763021964

Ovultell LH Urine Test Strip (4mm), 20 strips in Canister; hCG Urine Test Strip (4mm), 2 individually pouched strips and 5 Cups (Self-Testing) for Hemosure
HEMOSURE INC.
F5-OST20/2
In Commercial Distribution

  • 00817763021964 ()
  • 00817763021940 ()
F5-OST20/2

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

DESS dental smart solutions - 08435457211280

Int. Hex USA
TERRATS MEDICAL SL.
41.719/2
In Commercial Distribution

  • 08435457211280 ()
41.719/2

  • Dental implant suprastructure, permanent, preformed

DESS dental smart solutions - 08435457211242

Conical BL
TERRATS MEDICAL SL.
41.744/2
In Commercial Distribution

  • 08435457211242 ()
41.744/2

  • Dental implant suprastructure, permanent, preformed

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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