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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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Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable

Cardiac Function Laboratory - 08717953256645

Inca PV loop system for the measurement of cardiac function and performance.
CD Leycom
CFL-M Inca
In Commercial Distribution

  • 08717953256645 ()
CDL001

  • Cardiac mapping system

7 Fr PV-Catheter - 08719327737347

7 Fr PV-Loop catheter with 12 mm electrode spacing
CD Leycom
CA-71123-PL
In Commercial Distribution

  • 08719327737347 ()
CDL018

  • Intracardiac catheter-tip electrode

7 Fr PV-Catheter - 08719327737330

7 Fr PV Loop catheter with 10 mm electrode spacing
CD Leycom
CA-71103-PL
In Commercial Distribution

  • 08719327737330 ()
CDL017

  • Intracardiac catheter-tip electrode

7 Fr PV-Catheter - 08719327737323

7 French PV Loop Catheter with 8mm electrode spacing
CD Leycom
CA-71083-PL
In Commercial Distribution

  • 08719327737323 ()
CDL016

  • Intracardiac catheter-tip electrode

4 Fr PV Catheter - 08719327737316

4 Fr PV Loop catheter with 10 mm electrode spacing
CD Leycom
CA-41103-PN
In Commercial Distribution

  • 08719327737316 ()
CDL015

  • Intracardiac catheter-tip electrode

4 Fr PV Catheter - 08719327737309

4 French PV Loop catheter with 6 mm electrode spacing
CD Leycom
CA-41063-PN
In Commercial Distribution

  • 08719327737309 ()
CDL014

  • Intracardiac catheter-tip electrode

POWERWAND™ XL - 10859821006206

POWERWAND™ XL Max Barrier Kit 4Fr X 10cm
ICU MEDICAL, INC.
Max Barrier Kit 4Fr X 10cm
In Commercial Distribution

  • 20859821006203 ()
  • 10859821006206 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
94107

  • Peripheral vascular catheter

Certa Dose - 00860012210800

The Epinephrine Convenience Kit contains two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device is a 3/10 mL syringe that has mL graduation marks with color zones that align with color zones that correspond to pediatric weight ranges that can be used as a secondary confirmation that measured volumes are within ranges that are common for a patient’s weight. The Kit is intended for use in clinical and emergency medical settings to assist healthcare professionals and emergency medical personnel in measuring a desired volume of epinephrine for delivery to pediatric patients.
CD Acquisitions, LLC
1
In Commercial Distribution

  • 00860012210800 ()
  • 00860012210817 ()
  • 10860012210814 ()

  • Total Volume: 0.3 Milliliter
  • Length: 0.5 Inch
  • Needle Gauge: 29 Gauge
CD-EPI-001-NV

  • General-purpose syringe/needle

Certa Dose PALS Syringe Holder - 00860425001620

A small device intended to be used to clip to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is made of plastic material and designed to be clipped to the base of either a Luer or a Luer-lock syringe. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms. This is a single-use device
CD Acquisitions, LLC
CD-PALS-0001
In Commercial Distribution

  • 00860425001620 ()
  • 00860425001651 ()
  • 10860425001658 ()


  • Syringe/ampule clip

Synovasure® Alpha Defensin - 00887868358852

No Description
CD DIAGNOSTICS, INC.
00-8888-125-02
In Commercial Distribution

  • 00887868358852 ()
00-8888-125-02

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® - 00887868358845

No Description
CD DIAGNOSTICS, INC.
00-8888-125-30
In Commercial Distribution

  • 00887868358845 ()
  • 70887868358844 ()
00-8888-125-30

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® - 00887868358838

No Description
CD DIAGNOSTICS, INC.
00-8888-125-10
In Commercial Distribution

  • 00887868358838 ()
  • 70887868358837 ()
00-8888-125-10

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868358821

No Description
CD DIAGNOSTICS, INC.
00-8888-125-05
In Commercial Distribution

  • 00887868358821 ()
  • 70887868358820 ()
00-8888-125-05

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868358814

No Description
CD DIAGNOSTICS, INC.
00-8888-125-01
In Commercial Distribution

  • 00887868358814 ()
00-8888-125-01

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868540691

No Description
CD DIAGNOSTICS, INC.
00-8888-125-02
In Commercial Distribution

  • 00887868540691 ()
00-8888-125-02

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868540684

No Description
CD DIAGNOSTICS, INC.
00-8888-125-30
In Commercial Distribution

  • 00887868540684 ()
  • 70887868540683 ()
00-8888-125-30

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868540677

No Description
CD DIAGNOSTICS, INC.
00-8888-125-10
In Commercial Distribution

  • 00887868540677 ()
  • 70887868540676 ()
00-8888-125-10

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868540660

No Description
CD DIAGNOSTICS, INC.
00-8888-125-05
In Commercial Distribution

  • 70887868540669 ()
  • 00887868540660 ()
00-8888-125-05

  • Alpha defensin IVD, kit, rapid ICT, clinical

Synovasure® Alpha Defensin - 00887868540653

No Description
CD DIAGNOSTICS, INC.
00-8888-125-01
In Commercial Distribution

  • 00887868540653 ()
00-8888-125-01

  • Alpha defensin IVD, kit, rapid ICT, clinical

CellSearch - 10888385000016

Circulating Tumor Cell Kit (Epithelial)
MENARINI SILICON BIOSYSTEMS, INC.
7900001
In Commercial Distribution

  • 10888385000016 ()
7900001

  • Multiple CD cell marker IVD, kit, enzyme immunohistochemistry

Cochlear™ Custom Sound Suite Version 5 - 09321502038829

CD
COCHLEAR LIMITED
P772796
In Commercial Distribution

  • 09321502038829 ()
P772796

  • Audiometric/hearing device software

Torque ratchet - 04063494000785

No Description
Josef Ganter Feinmechanik GmbH
CD
In Commercial Distribution

  • 04063494000785 ()


  • Dental torque wrench

Mariner MIS - 10889981218515

CD Driver
Seaspine Orthopedics Corporation
MM2-100220
In Commercial Distribution

  • 10889981218515 ()
MM2-100220

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981178222

CD DRIVER
Seaspine Orthopedics Corporation
MM2-000220
In Commercial Distribution

  • 10889981178222 ()
MM2-000220

  • Orthopaedic implant driver

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Persona® The Personalized Knee System - 00889024204744

No Description
Zimmer, Inc.
00-5907-082-90
In Commercial Distribution

  • 00889024204744 ()

  • CD
00-5907-082-90

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee System - 00889024203426

No Description
Zimmer, Inc.
00-5907-080-76
In Commercial Distribution

  • 00889024203426 ()

  • C-D
00-5907-080-76

  • Device sterilization/disinfection container, reusable

Media Writer CD - 00850677007136

Media Writer CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007136 ()


  • Radiology DICOM image processing application software

Mariner Deformity - 10889981293161

CD Tip, Offset
Seaspine Orthopedics Corporation
MD2-103016
In Commercial Distribution

  • 10889981293161 ()
MD2-103016

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981293154

CD Tip, Straight
Seaspine Orthopedics Corporation
MD2-103015
In Commercial Distribution

  • 10889981293154 ()
MD2-103015

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981178499

CD MAIN ARM
Seaspine Orthopedics Corporation
MM2-000520
In Commercial Distribution

  • 10889981178499 ()
MM2-000520

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981178406

CD TOWER ARM
Seaspine Orthopedics Corporation
MM2-000420
In Commercial Distribution

  • 10889981178406 ()
MM2-000420

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981218546

CD Main Arm
Seaspine Orthopedics Corporation
MM2-100520
In Commercial Distribution

  • 10889981218546 ()
MM2-100520

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981218522

CD Tower Arm
Seaspine Orthopedics Corporation
MM2-100420
In Commercial Distribution

  • 10889981218522 ()
MM2-100420

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DMC-EZ - 00850018049115

DICOM CD Viewer
Storage Solutions Technology Group Inc.
DMC-EZ DICOM
In Commercial Distribution

  • 00850018049115 ()
DMC-EZ DICOM

  • Multidisciplinary medical image management software

Medtronic Reusable Instruments - 00673978156057

CD 84604 SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
X1295-001
Not in Commercial Distribution

  • 00673978156057 ()


  • Bone distraction forceps

GN ReSound - 05708296222155

CD, AVENTA 2.9
Gn Hearing A/S
16861900
In Commercial Distribution

  • 05708296222155 ()


  • Audiometric/hearing device software

Actiware - 00606959021457

Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder

Custom Sound Suite 4.4 CD - 09321502033381

Version 4.4 CD
COCHLEAR LIMITED
P705394
In Commercial Distribution

  • 09321502033381 ()
P705394

  • Audiometric/hearing device software

EAGLESOFT - 00350227000254

DIGITAL INTEGRATION CD
PATTERSON TECHNOLOGY CENTER
21.10
In Commercial Distribution

  • 00350227000254 ()


  • Radiological PACS software

EAGLESOFT - 00350227000162

DIGITAL INTEGRATION CD
PATTERSON TECHNOLOGY CENTER
21.00
In Commercial Distribution

  • 00350227000162 ()


  • Radiological PACS software

EAGLESOFT - 00350227000063

DICOM NETWORK CD
PATTERSON TECHNOLOGY CENTER
18.10
In Commercial Distribution

  • 00350227000063 ()


  • Radiological PACS software

EAGLESOFT - 00350227000056

DICOM MEDIA CD
PATTERSON TECHNOLOGY CENTER
18.10
In Commercial Distribution

  • 00350227000056 ()


  • Radiological PACS software

EAGLESOFT - 00350227000049

DIGITAL INTEGRATION CD
PATTERSON TECHNOLOGY CENTER
18.10
In Commercial Distribution

  • 00350227000049 ()


  • Radiological PACS software

CELL-DYN - 00380740192402

CD EZ CLEANER
ABBOTT LABORATORIES
09H6003
In Commercial Distribution

  • 00380740192402 ()
09H6003

  • Buffered wash solution IVD

Natus - 00382830041751

Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software

MICROETCHER - 00816594021549

MICROETCHER CD,SIRONA
DANVILLE MATERIALS, LLC
201935-00
In Commercial Distribution

  • 00816594021549 ()
201935-00

  • Dental abrasive air jet system

MICROETCHER - 00816594021532

MICROETCHER CD, KAVO
DANVILLE MATERIALS, LLC
201936-00
In Commercial Distribution

  • 00816594021532 ()
201936-00

  • Dental abrasive air jet system

Brasseler USA - 00887919805656

A637BLACK CD ST-GABRIEL-BRANDON
Peter Brasseler Holdings, LLC
5026605U0
In Commercial Distribution

  • 00887919805656 ()


  • Diamond dental bur, single-use
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