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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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TRACOE® comfort - 04035324026302

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-14A-O
Not in Commercial Distribution

  • 04035324026302 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324026227

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-13A-O
Not in Commercial Distribution

  • 04035324026227 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324026135

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-12A-O
Not in Commercial Distribution

  • 04035324026135 ()

  • Lumen/Inner Diameter: 10.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324025862

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-09A-O
Not in Commercial Distribution

  • 04035324025862 ()

  • Lumen/Inner Diameter: 7.5 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324025770

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-08A-O
Not in Commercial Distribution

  • 04035324025770 ()

  • Lumen/Inner Diameter: 6.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324025688

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-07A-O
Not in Commercial Distribution

  • 04035324025688 ()

  • Lumen/Inner Diameter: 6.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324025596

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-06A-O
Not in Commercial Distribution

  • 04035324025596 ()

  • Lumen/Inner Diameter: 5.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324025503

Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-05A-O
Not in Commercial Distribution

  • 04035324025503 ()

  • Lumen/Inner Diameter: 4.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324022342

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-09A-O
Not in Commercial Distribution

  • 04035324022342 ()

  • Lumen/Inner Diameter: 7.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324022250

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-08A-O
Not in Commercial Distribution

  • 04035324022250 ()

  • Lumen/Inner Diameter: 6.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324022175

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-07A-O
Not in Commercial Distribution

  • 04035324022175 ()

  • Lumen/Inner Diameter: 5.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324022083

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-06A-O
Not in Commercial Distribution

  • 04035324022083 ()

  • Lumen/Inner Diameter: 4.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324021994

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-05A-O
Not in Commercial Distribution

  • 04035324021994 ()

  • Lumen/Inner Diameter: 4.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324021901

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-04A-O
Not in Commercial Distribution

  • 04035324021901 ()

  • Lumen/Inner Diameter: 3.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324021826

Tube,Fenestrated, with Swivel Speaking Valve, Type B,with additional oxygen supply port and with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-104-03A-O
Not in Commercial Distribution

  • 04035324021826 ()

  • Lumen/Inner Diameter: 2.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

MRI Stretcher with Fowler Positioning - 00879942070767

The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution

  • 00879942070767 ()
240-110

  • MRI system table, non-powered

Multi wrench with ISO adapter - 05712821006431

The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C9866
In Commercial Distribution

  • 05712821006448 ()
  • 05712821006431 ()


  • Surgical torque wrench, reusable

Gabriel Feeding Tube with Balloon - 00860000931359

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
12 Fr
In Commercial Distribution

  • 10860000931356 ()
  • 00860000931359 ()

  • Catheter Gauge: 12 French
  • 12 FR (4.2mm)X 52”(130cm)
GFTB 512

  • Nasogastric feeding tube

Gabriel Feeding Tube with Balloon - 00860000931342

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
10 Fr
In Commercial Distribution

  • 10860000931349 ()
  • 00860000931342 ()

  • 10 Fr (3.7mm)X 49”(100cm)
  • Catheter Gauge: 10 French
GFTB 510

  • Nasogastric feeding tube

Gabriel Feeding Tube with Balloon - 00860000931335

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931332 ()
  • 00860000931335 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm)X 32”(80cm)
GFTB 508

  • Nasogastric feeding tube

Tracheostomy Care Tray with Gloves - 00860008059567

Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable

Avive AED with Avive Connect - 00860002508559

No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution

  • 00860002508559 ()


  • Rechargeable public automated external defibrillator

Archimedies Access Kit with Syringe - 00856571007234

A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
BRONCUS MEDICAL INC.
12196-09
In Commercial Distribution

  • 00856571007234 ()
10009-09

  • Lung biopsy procedure kit

microTargeting™ Controller with Motor - 00873263008263

microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00826
In Commercial Distribution

  • 00873263008263 ()
FC1008

  • Neurosurgical micro targeting drive

Hemorrhage Occluder Pin with Applicator - 00861838000316

Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.
TOOLS FOR SURGERY, LLC
HOP-AP
In Commercial Distribution

  • 00861838000316 ()

  • Length: 7 Millimeter
  • Outer Diameter: 10 Millimeter
HOP-AP

  • Skin stapler/staple, non-bioabsorbable

Prosomnus IA with Patient Monitoring - 00863039000430

Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
IA Monogram Monitor
In Commercial Distribution

  • 00863039000430 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Chang Medium MF with Gentamicin - 00857515006160

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium BMC with Gentamicin - 00857515006153

Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

ZipCombo Centrifuge with hematocrit rotor - 00664816001745

ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution

  • 00664816001745 ()


  • Microhaematocrit centrifuge IVD

DenteShield Sample Opaque with Fluoride - 00858290006598

DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution

  • 00858290006598 ()


  • Dental unfilled resin sealant/coating
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