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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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Rexious - 08809557204808

Poly Axial screw G type - 12.5x130 housing - 8.5 x 40
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204808 ()
RG.LR.8540

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

Rexious - 08809557204792

Poly Axial screw G type - 12.5x130 housing - 8.5 x 35
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204792 ()
RG.LR.8535

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

BIO-C TEMP - 07898078659915

Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 0.5 g
Angelus Industria de Produtos Odontologicos S A
BIO-C TEMP 0.5 g
In Commercial Distribution

  • 07898078659915 ()
2832

  • Endodontic filling/sealing material

BIO-C SEALER ION+ - 07898078659823

Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER ION+ 2 g
Angelus Industria de Produtos Odontologicos S A
BIO-C SEALER ION+ 2 g
In Commercial Distribution

  • 07898078659823 ()
3843

  • Endodontic filling/sealing material

BIO-C TEMP - 07898078658840

Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 2 g
Angelus Industria de Produtos Odontologicos S A
BIO-C TEMP 2 g
In Commercial Distribution

  • 07898078658840 ()
2833

  • Endodontic filling/sealing material

G-aenial™ - D0470084681

G-aenial™ Universal Flo AO1 (2 mL/3.4 g per syringe)
Gc America Inc.
008468
In Commercial Distribution

  • D0470084681 ()

  • Total Volume: 2 Milliliter
008468

  • Light-cured dental restorative composite resin

G-aenial™ - D0470042141

G-aenial™ CV, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004214
In Commercial Distribution

  • D0470042141 ()

  • Total Volume: 2 Milliliter
004214

  • Light-cured dental restorative composite resin

G-aenial™ - D0470042131

G-aenial™ BW, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004213
In Commercial Distribution

  • D0470042131 ()

  • Total Volume: 2 Milliliter
004213

  • Light-cured dental restorative composite resin

GRADIA® - D0470025901

GRADIA® DIRECT X Unitips - 20 - 0.16 mL/0.30 g -X-A1
Gc America Inc.
002590
In Commercial Distribution

  • D0470025901 ()
  • D0470025900 ()

  • Total Volume: 0.16 Milliliter
002590

  • Light-cured dental restorative composite resin

BLUE AND GREEN - 00840018649484

B&G EXPRO DOUBLE END WILLIAMS CC/EXPL#23, BG6 HANDLE
NORDENT MANUFACTURING INC
POW-23/BG6
In Commercial Distribution

  • 00840018649484 ()


  • Periodontal probe, reusable
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