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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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FAC-3 - Lawson Class B - 00766588150840

FAC-3 - Lawson Class B
Certified Safety Manufacturing, Inc.
K615-084
In Commercial Distribution

  • 00766588150840 ()
K615-084

  • Eye pad
  • First aid kit, medicated
  • Endothermic cold therapy pack
  • Adhesive bandage
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Cardiopulmonary resuscitation mask, single-use
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Non-woven gauze roll/sheet
  • Non-rebreathing valve, single-use

36M - Class B - Metal - 00766588150192

36M - Class B - Metal
Certified Safety Manufacturing, Inc.
K615-019
In Commercial Distribution

  • 00766588150192 ()
K615-019

  • Endothermic cold therapy pack
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Non-rebreathing valve, single-use
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Non-woven gauze roll/sheet
  • Adhesive bandage
  • First aid kit, medicated
  • Eye pad

AU - 15099590080778

APO A1 & B Calibrator
Beckman Coulter, Inc.
ODR3022
In Commercial Distribution

  • 15099590080778 ()


  • Multiple apolipoprotein IVD, calibrator

CERABIEN™ ZR - EKUR1043831KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
104-3831KA
In Commercial Distribution

  • EKUR1043831KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ - EKUR1031651KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
103-1651KA
In Commercial Distribution

  • EKUR1031651KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ - EKUR1031481KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
103-1481KA
In Commercial Distribution

  • EKUR1031481KA0 ()


  • Dental appliance fabrication material, ceramic

Noritake Super Porcelain EX-3 - EKUR1023821KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
102-3821KA
In Commercial Distribution

  • EKUR1023821KA0 ()


  • Dental appliance fabrication material, ceramic

Noritake Super Porcelain EX-3 - EKUR1023631KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
102-3631KA
In Commercial Distribution

  • EKUR1023631KA0 ()


  • Dental appliance fabrication material, ceramic

PANAVIA™ 21 - EKUR001054KA1

ED PRIMER Liquid B
KURARAY NORITAKE DENTAL INC.
#1054-KA
In Commercial Distribution

  • EKUR001054KA1 ()


  • Dental composite resin kit

CERABIEN™ ZR - EKUR1043651KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
104-3651KA
In Commercial Distribution

  • EKUR1043651KA0 ()


  • Dental appliance fabrication material, ceramic
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