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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 - 10381780119531

The Integra Total Foot System Flatline Arthrodesis Plate provides optimum stability for a variety of fusions.
Ascension Orthopedics, Inc.
2814005
In Commercial Distribution

  • M26928140051 ()
  • 10381780119531 ()

  • 14 mm
2814005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Surgical Direct - B382S344881000

5 1/8 Inch Elschnig Cyclodialysis Spatula Angled Flat 1mm Wide Tip On A Flat Handle
Surgical Direct, Inc.
S34488.100
In Commercial Distribution

  • B382S344881000 ()
S34488.100

  • Ocular hook/spatula/manipulator, reusable

Grandio SO - E22126011

Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide.
VOCO GmbH
2601
In Commercial Distribution

  • E22126011 ()
2601

  • Dentine adhesive
  • Dental composite resin

GETINGE CM320-SERIES - 07340153700215

CM320-4 CHAMBER WWWD. Washer disinfector with four chambers; Three washer chambers followed by a dryer chamber.
Getinge Disinfection AB
CM320
In Commercial Distribution

  • 07340153700215 ()
CM320WWWD

  • Surgical utensil washer/disinfector

Wavicide MEC Indicator - M44503060

The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutaraldehyde concentration of Wavicide-01.
MEDICAL CHEMICAL CORPORATION
0306-Strips
In Commercial Distribution

  • M44503060 ()
  • M44503061 ()
0306-Strips

  • Glutaraldehyde device disinfectant/sterilant test strip

FleXNeedle - 00856571007012

Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-1
In Commercial Distribution

  • 00856571007012 ()

  • Needle Gauge: 18 Gauge
10005-1

  • Soft-tissue biopsy needle, single-use

FleXNeedle (5 pack) - 00856571007210

Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-2
In Commercial Distribution

  • 00856571007210 ()

  • Needle Gauge: 18 Gauge
10005-2

  • Soft-tissue biopsy needle, single-use

Neodent - 07899878001782

SMART MOUNT
JJGC Indústria e Comércio de Materiais Dentários S/A.
113.046
In Commercial Distribution

  • 07899878001782 ()

  • Outer Diameter: 4.3 Millimeter
  • Outer Diameter: 4.1 Millimeter
113.046

  • Dental implant/prosthesis surgical procedure kit

TransCyte - 00618474000046

TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived

INTRAmatic 20 E - EKAV100311070

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
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