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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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GC CROWNTEK™ - D6584120681

GC CROWNTEK™ Refill Size, 5 crowns of one size Central Up R. (1 + .5)
Gc America Inc.
412068
Not in Commercial Distribution

  • D6584120681 ()
  • D6584120680 ()
412068

  • Preformed dental crown, temporary

BioHPP for2press - 20 g - EBRE540F2P260

BioHPP for2press - 20 g 5 pellets ds2 of 4 g each dentin-shade 2 5 Pieces
bredent GmbH & Co. KG
540F2P26
In Commercial Distribution

  • EBRE540F2P269 ()
  • EBRE540F2P260 ()
540F2P26

  • Dental bridge, polymer

BioHPP for2press - 75 g - EBRE540F2P240

BioHPP for2press - 75 g 5 pellets ds2 of 15 g each dentin-shade 2 5 Pieces
bredent GmbH & Co. KG
540F2P24
In Commercial Distribution

  • EBRE540F2P249 ()
  • EBRE540F2P240 ()
540F2P24

  • Dental bridge, polymer

Renamel Microhybrid Pedo Kit - D779606PED3

Renamel Microhybrid Pedo Kit includes 5 (5 g) syringes of Renamel Microhybrid in the Tray.
COSMEDENT, INC.
606PED
In Commercial Distribution

  • D779606PED3 ()
606PED

  • Dental composite resin

Novo Surgical - G586G93141230

zenith frazier skin hook, 5.0 mm wide, 5" (12.7 cm), sharp point, 5" (12.7 cm)
NOVO SURGICAL, INC.
G93141-23
In Commercial Distribution

  • G586G93141230 ()
G93141-23

  • Soft-tissue surgical hook, reusable

Integra® Miltex® - 10381780360032

Integra® Miltex® Janse-Wagner Retractor 4-1/8" Working Length, 5 X 5 Sharp Prongs
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
11-8
In Commercial Distribution

  • H8341180 ()
  • 10381780360032 ()
11-8

  • Self-retaining surgical retractor, reusable

Integra® Jarit® - 10381780404170

Integra® Jarit® Jansen-Wagner Retractor 4-1/8" Working Length, 5 x 5 Sharp Prongs
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X229
In Commercial Distribution

  • M274X2291 ()
  • 10381780404170 ()
X229

  • Self-retaining surgical retractor, reusable

Integra® Dermal Regeneration Template - 10381780032281

Integra® MATRIX WOUND DRESSING 2 in X 2 in (5 cm X 5 cm)
Integra Lifesciences Corporation
52021
In Commercial Distribution

  • M269520211 ()
  • 10381780032281 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter
  • Length: 2 Inch
  • Width: 2 Inch
52021

  • Animal-derived wound matrix dressing

Extend - D798EXK0

Reliance Extend LTR is intended for use as a lingual retention wire. Kit contains Kit includes 5 x 18mm, 5 x 20mm, 5 x 22mm, 5 x 24mm and 5 x 26 mm Extend TMA Wires. Kit also includes 25 measuring devices.
RELIANCE ORTHODONTIC PRODUCTS INC
EXK
In Commercial Distribution

  • D798EXK0 ()
EXK

  • Orthodontic wire

MedGyn Laminaria - M803021015

Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5 long
In Commercial Distribution

  • M803021015 ()
021015

  • Hygroscopic cervical dilator
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