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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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Trel XPress 300C - 10381780112594

Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c25
In Commercial Distribution

  • 10381780112594 ()
  • M386XPRES3C251 ()

  • 2.5cc
XPres3c25

  • Bone matrix implant, human-derived

Trel XPress 300C - 10381780112587

Trel-XPress 300c, 5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c05
In Commercial Distribution

  • 10381780112587 ()
  • M386XPRES3C051 ()

  • 5cc
XPres3c05

  • Bone matrix implant, human-derived

Trel XPress 300C - 10381780112570

Trel-XPress 300c, 10cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c10
In Commercial Distribution

  • M386XPRES3C101 ()
  • 10381780112570 ()

  • 10cc
XPres3c10

  • Bone matrix implant, human-derived

YASEE - 06972359499689

Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
QINGDAO YASEE MEDICAL DEVICE CO.,LTD
JN-163B
In Commercial Distribution

  • 06972359499689 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger

Aingeal 3-patch electrode - 05060484630037

The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesive, single lead electrode array, which is designed to be used in contact with the patient’s skin. The device is used in conjunction with the Aingeal Device in order to monitor vital signs for ECG, respiration, motion and temperature for ambulatory and non-ambulatory patients in a hospital environment. This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required.
INTELESENS LIMITED
PN1120
In Commercial Distribution

  • 25060484630031 ()
  • 15060484630034 ()
  • 05060484630037 ()


  • Electrocardiographic electrode, single-use

SONICflex 2008 - EKAV100593110

This is a medical device.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.
KaVo Dental GmbH
1.005.9311
In Commercial Distribution

  • EKAV100593110 ()
2008

  • Ultrasonic dental scaling/debridement system

SafeBreak - Vascular - 10860635000311

SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
Lineus Medical
A
In Commercial Distribution

  • 10860635000311 ()
2855-01-0001

  • Luer/Luer breakaway connector

INTERA - 00850014110130

Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Intera Oncology Inc.
AP-07004
In Commercial Distribution

  • 00850014110130 ()
AP07004

  • Hypodermic needle, single-use

GIBI HD - 00850007764234

Gastrointestinal Boundary Identification and Sizing Tube 40 French
Reshape Lifesciences Inc.
B-2040
Not in Commercial Distribution

  • 00850007764234 ()
B-2040

  • Gastric calibration tube

GIBI HD - 00850007764227

Gastrointestinal Boundary Identification and Sizing Tube 36 French
Reshape Lifesciences Inc.
B-2036
Not in Commercial Distribution

  • 00850007764227 ()
B-2036

  • Gastric calibration tube
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