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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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KALORE™ - D0470035961

KALORE™ Syringes (2 mL/4 g) GT
Gc America Inc.
003596
In Commercial Distribution

  • D0470035961 ()

  • Total Volume: 2 Milliliter
003596

  • Light-cured dental restorative composite resin

KALORE™ - D0470035951

KALORE™ Syringes (2 mL/4 g) NT
Gc America Inc.
003595
In Commercial Distribution

  • D0470035951 ()

  • Total Volume: 2 Milliliter
003595

  • Light-cured dental restorative composite resin

KALORE™ - D0470035941

KALORE™ Syringes (2 mL/4 g) CT
Gc America Inc.
003594
In Commercial Distribution

  • D0470035941 ()

  • Total Volume: 2 Milliliter
003594

  • Light-cured dental restorative composite resin

KALORE™ - D0470035931

KALORE™ Syringes (2 mL/4 g) DT
Gc America Inc.
003593
In Commercial Distribution

  • D0470035931 ()

  • Total Volume: 2 Milliliter
003593

  • Light-cured dental restorative composite resin

KALORE™ - D0470035921

KALORE™ Syringes (2 mL/4 g) WT
Gc America Inc.
003592
In Commercial Distribution

  • D0470035921 ()

  • Total Volume: 2 Milliliter
003592

  • Light-cured dental restorative composite resin

KALORE™ - D0470035911

KALORE™ Syringes (2 mL/4 g) XBW
Gc America Inc.
003591
In Commercial Distribution

  • D0470035911 ()

  • Total Volume: 2 Milliliter
003591

  • Light-cured dental restorative composite resin

KALORE™ - D0470035901

KALORE™ Syringes (2 mL/4 g) BW
Gc America Inc.
003590
In Commercial Distribution

  • D0470035901 ()

  • Total Volume: 2 Milliliter
003590

  • Light-cured dental restorative composite resin

KALORE™ - D0470035891

KALORE™ Syringes (2 mL/4 g) CVD
Gc America Inc.
003589
In Commercial Distribution

  • D0470035891 ()

  • Total Volume: 2 Milliliter
003589

  • Light-cured dental restorative composite resin

KALORE™ - D0470035881

KALORE™ Syringes (2 mL/4 g) CV
Gc America Inc.
003588
In Commercial Distribution

  • D0470035881 ()

  • Total Volume: 2 Milliliter
003588

  • Light-cured dental restorative composite resin

KALORE™ - D0470035871

KALORE™ Syringes (2 mL/4 g) D2
Gc America Inc.
003587
In Commercial Distribution

  • D0470035871 ()

  • Total Volume: 2 Milliliter
003587

  • Light-cured dental restorative composite resin

KALORE™ - D0470035861

KALORE™ Syringes (2 mL/4 g) C3
Gc America Inc.
003586
In Commercial Distribution

  • D0470035861 ()

  • Total Volume: 2 Milliliter
003586

  • Light-cured dental restorative composite resin

KALORE™ - D0470035851

KALORE™ Syringes (2 mL/4 g) C2
Gc America Inc.
003585
In Commercial Distribution

  • D0470035851 ()

  • Total Volume: 2 Milliliter
003585

  • Light-cured dental restorative composite resin

KALORE™ - D0470035841

KALORE™ Syringes (2 mL/4 g) B3
Gc America Inc.
003584
In Commercial Distribution

  • D0470035841 ()

  • Total Volume: 2 Milliliter
003584

  • Light-cured dental restorative composite resin

KALORE™ - D0470035831

KALORE™ Syringes (2 mL/4 g) B2
Gc America Inc.
003583
In Commercial Distribution

  • D0470035831 ()

  • Total Volume: 2 Milliliter
003583

  • Light-cured dental restorative composite resin

KALORE™ - D0470035821

KALORE™ Syringes (2 mL/4 g) B1
Gc America Inc.
003582
In Commercial Distribution

  • D0470035821 ()

  • Total Volume: 2 Milliliter
003582

  • Light-cured dental restorative composite resin

KALORE™ - D0470035811

KALORE™ Syringes (2 mL/4 g) A4
Gc America Inc.
003581
In Commercial Distribution

  • D0470035811 ()

  • Total Volume: 2 Milliliter
003581

  • Light-cured dental restorative composite resin

KALORE™ - D0470035801

KALORE™ Syringes (2 mL/4 g) A3.5
Gc America Inc.
003580
In Commercial Distribution

  • D0470035801 ()

  • Total Volume: 2 Milliliter
003580

  • Light-cured dental restorative composite resin

KALORE™ - D0470035791

KALORE™ Syringes (2 mL/4 g) A3
Gc America Inc.
003579
In Commercial Distribution

  • D0470035791 ()

  • Total Volume: 2 Milliliter
003579

  • Light-cured dental restorative composite resin

KALORE™ - D0470035781

KALORE™ Syringes (2 mL/4 g) A2
Gc America Inc.
003578
In Commercial Distribution

  • D0470035781 ()

  • Total Volume: 2 Milliliter
003578

  • Light-cured dental restorative composite resin

KALORE™ - D0470035771

KALORE™ Syringes (2 mL/4 g) A1
Gc America Inc.
003577
In Commercial Distribution

  • D0470035771 ()

  • Total Volume: 2 Milliliter
003577

  • Light-cured dental restorative composite resin

KALORE™ - D0470035761

KALORE™ Syringes (2 mL/4 g) OXBW
Gc America Inc.
003576
In Commercial Distribution

  • D0470035761 ()

  • Total Volume: 2 Milliliter
003576

  • Light-cured dental restorative composite resin

KALORE™ - D0470035751

KALORE™ Syringes (2 mL/4 g) OBW
Gc America Inc.
003575
In Commercial Distribution

  • D0470035751 ()

  • Total Volume: 2 Milliliter
003575

  • Light-cured dental restorative composite resin

KALORE™ - D0470035741

KALORE™ Syringes (2 mL/4 g) AO4
Gc America Inc.
003574
In Commercial Distribution

  • D0470035741 ()

  • Total Volume: 2 Milliliter
003574

  • Light-cured dental restorative composite resin

KALORE™ - D0470035731

KALORE™ Syringes (2 mL/4 g) AO3
Gc America Inc.
003573
In Commercial Distribution

  • D0470035731 ()

  • Total Volume: 2 Milliliter
003573

  • Light-cured dental restorative composite resin

KALORE™ - D0470035721

KALORE™ Syringes (2 mL/4 g)AO2
Gc America Inc.
003572
In Commercial Distribution

  • D0470035721 ()

  • Total Volume: 2 Milliliter
003572

  • Light-cured dental restorative composite resin

GC Fuji ORTHO™ - D0470002091

GC Fuji ORTHO™ 40 g powder btl
Gc America Inc.
000209
In Commercial Distribution

  • D0470002092 ()
  • D0470002091 ()

  • Weight: 40 Gram
000209

  • Glass ionomer dental cement

Miracle Mix® - D0470001231

Miracle Mix® 17 g alloy powder btl.
Gc America Inc.
000123
In Commercial Distribution

  • D0470001231 ()

  • Weight: 17 Gram
000123

  • Glass ionomer dental cement

MOBIO™ Total Knee System - 00843575101778

Tibial Keel Punch, Size D/E/F/G
B-ONE ORTHO, CORP.
8829214047
In Commercial Distribution

  • 00843575101778 ()
8829214047

  • Orthopaedic chisel

b-ONE™ Primary Acetabular System - 00843575100177

SHELL TRIAL, 52MM OUTER DIAMETER, LINER SIZE G
B-ONE ORTHO, CORP.
881906152G
In Commercial Distribution

  • 00843575100177 ()
881906152G

  • Acetabulum prosthesis trial, prefabricated, reusable

CER-SUB-1590 CE - 00850023741998

CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M
RANFAC CORP.
15 GA X 90 MM
In Commercial Distribution

  • 10850023741995 ()
  • 00850023741998 ()
  • 20850023741992 ()

  • Needle Gauge: 15 Gauge
  • Length: 90 Millimeter
CER-SUB-1590

  • Bone access cannula

MC-RAN-11C CE - 00850023741776

MC-RAN-11C F/G, STERILE CE P/N 74419-01M
RANFAC CORP.
MC-RAN-11C
In Commercial Distribution

  • 10850023741773 ()
  • 00850023741776 ()
  • 20850023741770 ()

  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
MC-RAN-11C

  • Bone access cannula

CER-EXT-M - 00850023741493

CER-EXT-M NEEDLE, F/G, STERILE, CE PN: 74400-01M
RANFAC CORP.
11 GA X 6.3 CM
In Commercial Distribution

  • 10850023741490 ()
  • 00850023741493 ()
  • 20850023741497 ()

  • Needle Gauge: 11 Gauge
  • Length: 6.3 Centimeter
CER-EXT-M

  • Bone access cannula

CER-ORTHO - 00850023741455

CER-ORTHO NEEDLE, F/G, STERILE, CE PN: 74396-01M
RANFAC CORP.
11 GA X 11.4 CM
In Commercial Distribution

  • 10850023741452 ()
  • 00850023741455 ()
  • 20850023741459 ()

  • Needle Gauge: 11 Gauge
  • Length: 11.4 Centimeter
CER-ORTHO

  • Bone access cannula

CER-EXT - 00850023741448

CER-EXT NEEDLE, F/G, STERILE, CE PN: 74395-01M
RANFAC CORP.
11 GA X 6.4 CM
In Commercial Distribution

  • 10850023741445 ()
  • 00850023741448 ()
  • 20850023741442 ()

  • Needle Gauge: 11 Gauge
  • Length: 6.4 Centimeter
CER-EXT

  • Bone access cannula

COMPLETE® SE VASCULAR - 00643169150829

STENT SC8150LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC8150LV
Not in Commercial Distribution

  • 00643169150829 ()

  • Stent Inner Diameter 8 MM
  • Length: 150.0 Millimeter


  • Peripheral artery stent, bare-metal

COMPLETE® SE VASCULAR - 00643169150812

STENT SC7150LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC7150LV
In Commercial Distribution

  • 00643169150812 ()

  • Stent Inner Diameter 7 MM
  • Length: 150.0 Millimeter


  • Peripheral artery stent, bare-metal

COMPLETE® SE VASCULAR - 00643169150805

STENT SC6150LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC6150LV
In Commercial Distribution

  • 00643169150805 ()

  • Length: 150.0 Millimeter
  • Stent Inner Diameter 6 MM


  • Peripheral artery stent, bare-metal

COMPLETE® SE VASCULAR - 00643169150799

STENT SC5150LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC5150LV
In Commercial Distribution

  • 00643169150799 ()

  • Length: 150.0 Millimeter
  • Stent Inner Diameter 5 MM


  • Peripheral artery stent, bare-metal

COMPLETE® SE VASCULAR - 00643169150782

STENT SC5120LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC5120LV
In Commercial Distribution

  • 00643169150782 ()

  • Stent Inner Diameter 5 MM
  • Length: 120.0 Millimeter


  • Peripheral artery stent, bare-metal

COMPLETE® SE VASCULAR - 00643169150775

STENT SC5100LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC5100LV
In Commercial Distribution

  • 00643169150775 ()

  • Length: 100.0 Millimeter
  • Stent Inner Diameter 5 MM


  • Peripheral artery stent, bare-metal
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