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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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Dakota ALIF System - 00840019963022

33 X 27 X 15mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0015-2C
Not in Commercial Distribution

  • 00840019963022 ()
69-AM-0015-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963015

33 X 27 X 13mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0013-2C
Not in Commercial Distribution

  • 00840019963015 ()
69-AM-0013-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963008

33 X 27 X 11mm X 0° PEEK-2C
PRECISION SPINE, INC.
69-AM-0011-2C
Not in Commercial Distribution

  • 00840019963008 ()
69-AM-0011-2C

  • Polymeric spinal interbody fusion cage

Rumex - 00840159907474

Rainin Nucleus Hydrodissector, Spatulated, 27 Ga, Horizontally Spatulated
RUMEX INTERNATIONAL CORP.
15-070
In Commercial Distribution

  • 00840159907474 ()
15-070

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Rumex - 00840159907122

Asymmetrical End Grasping Forceps, 27 Ga, Tip Only
RUMEX INTERNATIONAL CORP.
12-420-27
In Commercial Distribution

  • 00840159907122 ()
12-420-27

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Rumex - 00840159905074

Eckardt End Gripping Forceps, 27 Ga, Tip Only
RUMEX INTERNATIONAL CORP.
12-410-27
In Commercial Distribution

  • 00840159905074 ()
12-410-27

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

LEONE SPA - 08033707034377

WEB 1ST MOL BANDS W/G8084-13 UL 27
LEONE SPA
E8830-27
In Commercial Distribution

  • 08033707034377 ()
E8830-27

  • Orthodontic metal band

LEONE SPA - 08033707034032

WEB 1ST MOL BANDS W/G8084-12 UR 27
LEONE SPA
E8820-27
In Commercial Distribution

  • 08033707034032 ()
E8820-27

  • Orthodontic metal band

LEONE SPA - 08033707031413

WEB 1ST MOL BANDS W/G8325-06 LR 27
LEONE SPA
E8560-27
In Commercial Distribution

  • 08033707031413 ()
E8560-27

  • Orthodontic metal band

LEONE SPA - 08033707028734

BANDE WASHBON I MOL SUP S N.UL 27
LEONE SPA
E8303-927
In Commercial Distribution

  • 08033707028734 ()
E8303-927

  • Orthodontic metal band
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