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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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Filter for dialysate purification - 04987671030214

The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
NIKKISO CO.,LTD.
EF-02D
In Commercial Distribution

  • 24987671030218 ()
  • 04987671030214 ()


  • Haemodialysis system dialysate pyrogen filter

StealthStation® AXIEM™ System - 00763000241483

AXIEM KIT 9732750 PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00763000241483 ()


  • Stereotactic surgery system workstation

IntelliSpace Portal IX - 00884838083653

The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083653 ()


  • CT system workstation

IntelliSpace Portal - 00884838083646

The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
Philips Medical Systems Nederland B.V.
6.5
Not in Commercial Distribution

  • 00884838083646 ()


  • CT system workstation

Invivo - 00884838081758

SensaVue Cart Assembly
Philips DS North America LLC
4535-303-46291
Not in Commercial Distribution

  • 00884838081758 ()
453530346291

  • MRI system workstation

SmartByte Device - 00860001615326

Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.
SCIENTIFIC INTAKE LIMITED CO.
SI-001.01
In Commercial Distribution

  • 00860001615326 ()


  • Oral intake restriction kit

OPTION, NL4X00 WS-240V - 10815411020816

No Description
NEUROLOGICA CORP.
0-00132-003
In Commercial Distribution

  • 10815411020816 ()


  • CT system workstation

Mobile ENT Computer Cart, Assembly - 10815411020212

No Description
NEUROLOGICA CORP.
10-00159-001
In Commercial Distribution

  • 10815411020212 ()


  • CT system workstation

OPTION, NL4X00 WS-120V-S - 10815411020823

No Description
NEUROLOGICA CORP.
0-00132-001
In Commercial Distribution

  • 10815411020823 ()


  • CT system workstation

OPTION, NL4X00 WS-240V-S - 10815411020809

No Description
NEUROLOGICA CORP.
0-00132-002
In Commercial Distribution

  • 10815411020809 ()


  • CT system workstation
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