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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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Solarc/SolRx 100-Series - B219110UVB0

Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-BROADBAND Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
110UVB
In Commercial Distribution

  • B219110UVB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use

SureFil® High Density Posterior Restorative - D0026452210

SureFil® High Density Posterior Restorative Refill Package, Syringe, Shade B, 1 (3g)
DENTSPLY INTERNATIONAL INC.
645221
In Commercial Distribution

  • D0026452210 ()

  • 1 Syringe (3g) Shade B
  • Weight: 3 Gram
645221

  • Dental composite resin

iTotal® Hip Replacement System - M572HDL060B14S011

HIP-IPOLY XE-LINER-GRP B (46-49) 32MM LAT STD
Conformis, Inc.
HDL060B14S01
In Commercial Distribution

  • M572HDL060B14S011 ()

  • Group B 32mm +4 STD
HDL060B14S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060B12S011

HIP-IPOLY XE-LINER-GRP B (46-49) 32MM STD (PLN)
Conformis, Inc.
HDL060B12S01
In Commercial Distribution

  • M572HDL060B12S011 ()

  • Group B 32mm +2 STD
HDL060B12S

  • Non-constrained polyethylene acetabular liner

Ceramco® II - D0012657110

Universal G and B Shades High-Value Red-Yellow
Dentsply International Inc.
Chroma Modifiers
Not in Commercial Distribution

  • D0012657110 ()

  • Weight: 28.4 Gram
265711

  • Dental appliance fabrication material, ceramic

Ceramco® II - D0012657010

Universal G and B Shades High-Value Red-Brown
Dentsply International Inc.
Chroma Modifiers
Not in Commercial Distribution

  • D0012657010 ()

  • Weight: 28.4 Gram
265701

  • Dental appliance fabrication material, ceramic

Ceramco® II - D0012621110

Universal G and B Shades High-Value Red-Yellow
Dentsply International Inc.
Chroma Modifiers
Not in Commercial Distribution

  • D0012621110 ()

  • Weight: 28.4 Gram
262111

  • Dental appliance fabrication material, ceramic

Ceramco® II - D0012621010

Universal G and B Shades High-Value Red-Brown
Dentsply International Inc.
Chroma Modifiers
Not in Commercial Distribution

  • D0012621010 ()

  • Weight: 28.4 Gram
262101

  • Dental appliance fabrication material, ceramic

OPTIGLAZE™ - D0470084101

OPTIGLAZE™ Color B plus (2.6 mL)
Gc America Inc.
008410
In Commercial Distribution

  • D0470084101 ()

  • Total Volume: 2.6 Milliliter
008410

  • Dental unfilled resin sealant/coating

ceraMotion® - J011250307030

cM Paste 2D B / dental ceramic material
DENTAURUM GmbH & Co.KG
250-307-03
In Commercial Distribution

  • J011250307030 ()


  • Dental appliance fabrication material, ceramic
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