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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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Nexcomp Flow intro Kit - 08806387860006

Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3-A3.5-A3.5)
Meta Biomed Co., Ltd.
6000
In Commercial Distribution

  • 08806387860006 ()


  • Dental composite resin

Earlens Fidelity Software - 00850013007417

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software

Earlens ELF USB - 00850013007042

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software

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

SURFIX® - 10381780044666

The SURFIX® compressor is used for closing the resected angle when a closing osteotomy is implemented
NEWDEAL
MA043ND
In Commercial Distribution

  • M248MA043ND1 ()
  • 10381780044666 ()


  • Surgical flat-nosed pliers

Integra® External Fixation System - 10381780125266

The nut is made from stainless steel and is used to secure the strut into the ring.
Ascension Orthopedics, Inc.
12224255
In Commercial Distribution

  • 10381780125266 ()

  • 10 mm hex x 5 mm H
12224255

  • External orthopaedic fixation system, reusable

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
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