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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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CC/ Pearl Enamel PS-1 blue/white
KLEMA Dentalprodukte GmbH
000282
In Commercial Distribution

  • ECWG0002821 ()
000282

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-04 light orange
KLEMA Dentalprodukte GmbH
000268
In Commercial Distribution

  • ECWG0002681 ()
000268

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-03 heavy yellow
KLEMA Dentalprodukte GmbH
000267
In Commercial Distribution

  • ECWG0002671 ()
000267

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-02 medium yellow
KLEMA Dentalprodukte GmbH
000266
In Commercial Distribution

  • ECWG0002661 ()
000266

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-01 light yellow
KLEMA Dentalprodukte GmbH
000265
In Commercial Distribution

  • ECWG0002651 ()
000265

  • Dental appliance fabrication material, ceramic
CC/ Bleach Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
000250
In Commercial Distribution

  • ECWG0002501 ()
000250

  • Dental appliance fabrication material, ceramic
Case ASM, IMP, CC Cann, 8.5
Xtant Medical Holdings, Inc.
1509-200160
In Commercial Distribution

  • 00840311252152 ()


  • Instrument tray, reusable
Case ASM, IMP, CC Cann, 4.5
Xtant Medical Holdings, Inc.
1509-200150
In Commercial Distribution

  • 00840311252145 ()


  • Instrument tray, reusable
Screw, Poly, MIS, CC Cann, 9.5x120
Surgalign Spine Technologies, Inc.
150152-95120
In Commercial Distribution

  • 00840311205431 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x110
Surgalign Spine Technologies, Inc.
150152-95110
In Commercial Distribution

  • 00840311205417 ()


  • Bone-screw internal spinal fixation system, non-sterile
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