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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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DragonFly™ Skinny BUR,100MM x 0.5MM - 00844505012478

DragonFly™ ROUND DIAMOND "Skinny" BUR 100MM LENGTH, 0.5MM Ø, Rx ONLY-USED WITH 950-002 HANDPIECE
Grace Medical, Inc.
951-100-005-SB
In Commercial Distribution

  • 00844505012478 ()


  • Diamond ENT bur, single-use

ROLAND DIRECTIONAL S/I, 7FR. x 10CM - 00844505011358

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 7FR. x 10CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR7-10
In Commercial Distribution

  • 00844505011358 ()


  • Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 12FR. x 8CM - 00844505011334

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 12FR. x 8CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR12-8
In Commercial Distribution

  • 00844505011334 ()


  • Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 10FR. x 8CM - 00844505011327

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 10FR. x 8CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR10-8
In Commercial Distribution

  • 00844505011327 ()


  • Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 7FR. x 8CM - 00844505011310

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 7FR. x 8CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR7-8
In Commercial Distribution

  • 00844505011310 ()


  • Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 5FR. x 10CM - 00844505011303

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 5FR. x 10CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR5-10
In Commercial Distribution

  • 00844505011303 ()


  • Surgical irrigation/aspiration handpiece, reusable

ROLAND DIRECTIONAL S/I, 5FR. x 8CM - 00844505011297

ROLAND DIRECTIONAL SUCTION IRRIGATOR, 5FR. x 8CM, STAINLESS STEEL
Grace Medical, Inc.
991-TR5-8
In Commercial Distribution

  • 00844505011297 ()


  • Surgical irrigation/aspiration handpiece, reusable

4.5 x 150 mm Surgibit Drill Percutaneous - 09348215061999

The saleable unit (device count) is 1, there are 5 surgibit drills in the saleable unit
SIGNATURE ORTHOPAEDICS PTY LTD
192-11-1545
In Commercial Distribution

  • 09348215061999 ()


  • Fluted surgical drill bit, reusable

Gt. x Human IgA (a) FITC Conjugate - 10190302009034

No Description
LIFE TECHNOLOGIES CORPORATION
H14001
In Commercial Distribution

  • 10190302009034 ()


  • Multiple CD cell marker IVD, reagent

AOS Drill, AO Style 3.2mm x 165mm - 00848665013986

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0229
In Commercial Distribution

  • 00848665013986 ()


  • Fluted surgical drill bit, single-use, non-sterile
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