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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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Creation Willi Geller - ECWG0002811

CC/ Pearl Enamel PS-0 white
KLEMA Dentalprodukte GmbH
000281
In Commercial Distribution

  • ECWG0002811 ()
000281

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002561

CC/ Bleach Shoulder SP-AB 15g
KLEMA Dentalprodukte GmbH
000256
In Commercial Distribution

  • ECWG0002561 ()
000256

  • Dental appliance fabrication material, ceramic

General Instruments - 00840180537251

INSIGNIA CC DS GUIDE, SP
ALPHATEC SPINE, INC.
CI-11783-CC15
In Commercial Distribution

  • 00840180537251 ()


  • Surgical drill guide, reusable

General Instruments - 00840180536407

INSIGNIA CC VA DS GUIDE
ALPHATEC SPINE, INC.
CI-11753-CC
In Commercial Distribution

  • 00840180536407 ()


  • Surgical drill guide, reusable

General Instrument - 00840180511718

Modular OCT Screw Tip, CC
ALPHATEC SPINE, INC.
CI-11087-CC
In Commercial Distribution

  • 00840180511718 ()


  • Surgical implant handling forceps

I/C Graft Chamber ® - 00889858395519

IC Graft Chamber - 15 cc
LIFENET HEALTH
GDS015T
In Commercial Distribution

  • 00889858395519 ()

  • LARGE/15 cc
GDS015T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395472

IC Graft Chamber - 10 cc
LIFENET HEALTH
GDS010T
In Commercial Distribution

  • 00889858395472 ()

  • MEDIUM/10 cc
GDS010T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395434

IC Graft Chamber - 5 cc
LIFENET HEALTH
GDS005T
In Commercial Distribution

  • 00889858395434 ()

  • SMALL/5 cc
GDS005T

  • Bone graft syringe, single-use

Darby Dental Supply, LLC - 00889813040928

FILES HED CC 25MM #8
DARBY DENTAL SUPPLY, LLC
9512440
In Commercial Distribution

  • 00889813040911 ()
  • 00889813040928 ()
9512440

  • Manual endodontic file/rasp, single-use

Darby Dental Supply, LLC - 00889813040904

FILES HED CC 21MM #8
DARBY DENTAL SUPPLY, LLC
9512417
In Commercial Distribution

  • 00889813040898 ()
  • 00889813040904 ()
9512417

  • Manual endodontic file/rasp, single-use
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