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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GLO MOUTHGUARD PINK (DZ) *I
Great Lakes Dental Technologies, Ltd.
191-022
In Commercial Distribution

  • D7751910221 ()
191-022

  • Mouthguard, reusable
ORTHOSET® I BONE CEMENT
Microport Orthopedics Inc.
14101000
In Commercial Distribution

  • 14101000 ()
  • M684141010001 ()
14101000

  • Orthopaedic cement, non-antimicrobial
Ethnic "L" Soft Type I
FRICKE INTERNATIONAL, INC.
24016-020
In Commercial Distribution

  • B715240160200 ()

  • Weight: 48 Gram
24016-020

  • Dental appliance fabrication material, resin
Ethnic "M" Soft Type I
FRICKE INTERNATIONAL, INC.
24007-020
In Commercial Distribution

  • B715240070200 ()

  • Weight: 48 Gram
24007-020

  • Dental appliance fabrication material, resin
Simcoe I/A Cannula 23G
EPSILON EYE CARE PRIVATE LIMITED
CA-605
In Commercial Distribution

  • G346CA6050 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Red AccuFilm® I Single-Sided
PARKELL, INC.
Red
In Commercial Distribution

  • M595S0151 ()
  • 10810000526083 ()
  • 00810000526086 ()
S015

  • Dental articulation paper
Black AccuFilm® I Single-Sided
PARKELL, INC.
Black
In Commercial Distribution

  • M595S0141 ()
  • 10810000526076 ()
  • 00810000526079 ()
S014

  • Dental articulation paper
Sterilization Case I, Atrix-C, Instruments
Xtant Medical Holdings, Inc.
X094-0003
In Commercial Distribution

  • M697X09400030 ()
  • M697X09400031 ()


  • Cadaveric-donor bone allograft
Sterilization Case I, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0004
In Commercial Distribution

  • M697X07300040 ()
  • M697X07300041 ()


  • Device sterilization/disinfection container, reusable
LOCAL LOWER EXTREMITY PACK I
Aligned Medical Solutions
AMS10833
In Commercial Distribution

  • B098AMS108331 ()
  • B098AMS108330 ()
AMS10833

  • General surgical procedure kit, non-medicated, single-use
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