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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SureFil® SDR® flow+ Bulk Flow Fillable Syringe Refill
DENTSPLY INTERNATIONAL INC.
61C130
Not in Commercial Distribution

  • D00261C1301 ()
  • D00261C1300 ()

  • 2 syringes (1g each) and 15 syringe tips - universal shade
  • Weight: 1 Gram
61C130

  • Dental composite resin
No Description
IVOCLAR VIVADENT, INC.
584121
Not in Commercial Distribution

  • D7075841210 ()
584121

  • Dental casting non-noble alloy
No Description
IVOCLAR VIVADENT, INC.
584116
Not in Commercial Distribution

  • D7075841160 ()
584116

  • Dental casting noble alloy
No Description
IVOCLAR VIVADENT, INC.
584115
Not in Commercial Distribution

  • D7075841150 ()
584115

  • Dental casting noble alloy
No Description
IVOCLAR VIVADENT, INC.
584114
Not in Commercial Distribution

  • D7075841140 ()
584114

  • Dental casting noble alloy
TF, ESI, SI, HIP Tray
ROBERT BUSSE & CO., INC.
9595
In Commercial Distribution

  • 10849233011196 ()
  • 00849233011199 ()
9595

  • Epidural anaesthesia set, medicated
Maxima Suture PTFE TF 13mm
HENRY SCHEIN, INC.
1127257
In Commercial Distribution

  • 10304040001209 ()
  • 00304040001202 ()
1127257

  • Polytetrafluoroethylene suture
Cranial Perforator
ACRA-CUT INC
200-500 14/9 mm
In Commercial Distribution

  • 00810607000118 ()
200-500 SDR

  • Cranial trephine, single-use
SureFil® SDR® flow+ Compula® Tips Refill Package - Shade A1
DENTSPLY INTERNATIONAL INC.
61C106
In Commercial Distribution

  • D00261C1061 ()
  • D00261C1060 ()

  • 15 Compula® Tips (0.25g each) - Shade A1
  • Weight: 0.25 Gram
61C106

  • Dental composite resin
SureFil® SDR® flow+ Compula® Tips Bulk Refill - Universal Shade
DENTSPLY INTERNATIONAL INC.
61C103
In Commercial Distribution

  • D00261C1031 ()
  • D00261C1030 ()

  • 50 Compula® tips-Universal Shade (0.25g each)
  • Weight: 0.25 Gram
61C103

  • Dental composite resin
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