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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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Integra® Total Foot System - 10381780118428

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830018
In Commercial Distribution

  • 10381780118428 ()
  • M26828300181 ()

  • 18 mm L x 3.5 mm dia
2830018

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

Integra® Total Foot System - 10381780118411

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830016
In Commercial Distribution

  • 10381780118411 ()
  • M26828300161 ()

  • 16 mm L x 3.5 mm dia
2830016

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

Integra® Total Foot System - 10381780118404

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830014
In Commercial Distribution

  • 10381780118404 ()
  • M26828300141 ()

  • 14 mm L x 3.5 mm dia
2830014

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

Integra® Total Foot System - 10381780118398

The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830012
In Commercial Distribution

  • 10381780118398 ()
  • M26828300121 ()

  • 12 mm L x 3.5 mm dia
2830012

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

Integra® Total Foot System - 10381780118701

The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835010
In Commercial Distribution

  • 10381780118701 ()
  • M26828350101 ()

  • 10 mm L x 2.7 mm dia
2835010

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

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

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

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

SmartLite Focus - D010644500701

SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp

BandLok - D798NFBLSA0

BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade. This is a NonFluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
NFBLSA
In Commercial Distribution

  • D798NFBLSA0 ()
NFBLSA

  • Orthodontic bracket adhesive
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