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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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SciPharm Cure-On Touch Orthodontic Adhesive - D801SP65121

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syringe.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-12
In Commercial Distribution

  • D801SP65121 ()
65-12

  • Dentine adhesive

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID6512I1

Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive

SmartLite Focus - D010644500501

SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450050
In Commercial Distribution

  • D010644500501 ()

  • Length: 7.5 Centimeter
64450050

  • Dental/surgical polymerization lamp

SmartLite Focus - D010644500211

SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450021
In Commercial Distribution

  • D010644500211 ()

  • Length: 5.9 Centimeter
64450021

  • Dental/surgical polymerization lamp

Lucitone® 199 - D0019882980

Light. This is sold as part of the 11-Unit Package (688203) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019882980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin

SURFIX® - 10381780051893

The axial compression clamp is used to allow a compression and is used with the 115425ND K-Wire.
NEWDEAL
219900ND
In Commercial Distribution

  • M248219900ND1 ()
  • 10381780051893 ()


  • Bone holding forceps

VSI Torque Device - M20681810

The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Vascular Solutions, Inc.
8181
Not in Commercial Distribution

  • M20681810 ()
  • M20681811 ()


  • Torque manipulation device

NES Reprocessed RF Stylet (RFS) - B227RRFS2612

The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.
NORTH EAST SCIENTIFIC INC
R-RFS2-6-12
Not in Commercial Distribution

  • B227RRFS2612 ()
R-RFS2-6-12

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal

Integra® Total Foot System - 10381780118503

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830035
In Commercial Distribution

  • 10381780118503 ()
  • M26828300351 ()

  • 35 mm L x 3.5 mm dia
2830035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Integra® Total Foot System - 10381780118480

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830030
In Commercial Distribution

  • 10381780118480 ()
  • M26828300301 ()

  • 30 mm L x 3.5 mm dia
2830030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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