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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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The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-20HP3E
In Commercial Distribution

  • 10868277000454 ()
  • 00868277000457 ()
  • 20868277000451 ()


  • Haemodialysis system dialysate pyrogen filter
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
FILTER, DIASAFE PLUS
Fresenius Medical Care AG
5008201
In Commercial Distribution

  • 04039361001391 ()
  • 04039361001384 ()

  • Area/Surface Area: 2.2 Square meter
5008203

  • Haemodialysis system dialysate pyrogen filter
Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter
No Description
Fresenius Medical Care Renal Therapies Group, LLC
F00007039
In Commercial Distribution

  • 10840861102133 ()
  • 00840861102136 ()

  • Area/Surface Area: 2.1 Square meter
F00007039

  • Haemodialysis system dialysate pyrogen filter
Planning Workstation (US)
KOH YOUNG TECHNOLOGY INC.
KY-PWS-0030-B
In Commercial Distribution

  • 08800050902666 ()


  • Stereotactic surgery system workstation
Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • Haemodialysis system dialysate pyrogen filter
The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.). Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it. CONTRAINDICATIONS Medical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used. Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
NEPHROS, INC.
W2T912244
In Commercial Distribution

  • 00896241002732 ()
  • 10896241002739 ()
  • 20896241002736 ()
70-0251M

  • Haemodialysis system dialysate pyrogen filter
The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0251P
In Commercial Distribution

  • 10896241002623 ()
  • 00896241002626 ()
  • 20896241002620 ()


  • Haemodialysis system dialysate pyrogen filter
AXIEM KIT 9732750 PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00763000241483 ()


  • Stereotactic surgery system workstation
AXIEM KIT, 9732750, PORTABLE PRE-BUILD
MEDTRONIC NAVIGATION, INC.
9732750
In Commercial Distribution

  • 00613994109477 ()


  • Stereotactic surgery system workstation
Kit Contains: R138 Montana Jack® Scaler R061 Barnhart 5-6 R030 Amazing Gracey™ 15-16
PDT, INC.
R908 - PDT Demo Wallet 3 Pack - Hygiene
In Commercial Distribution

  • 00813677025210 ()
R908

  • Periodontal curette
  • Manual dental scaler, reusable
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
No Description
NEUROLOGICA CORP.
0-00132-001
In Commercial Distribution

  • 10815411020823 ()


  • CT system workstation
No Description
NEUROLOGICA CORP.
0-00132-003
In Commercial Distribution

  • 10815411020816 ()


  • CT system workstation
No Description
NEUROLOGICA CORP.
0-00132-002
In Commercial Distribution

  • 10815411020809 ()


  • CT system workstation
No Description
NEUROLOGICA CORP.
0-00132-001
In Commercial Distribution

  • 10815411020229 ()


  • CT system workstation
No Description
NEUROLOGICA CORP.
10-00159-001
In Commercial Distribution

  • 10815411020212 ()


  • CT system workstation
No Description
NEUROLOGICA CORP.
0-00116-001
In Commercial Distribution

  • 10815411020106 ()


  • CT system workstation
TruSPECT Radiological Image Processing Station
SPECTRUM DYNAMICS MEDICAL, INC
STANDALONE PROCESSING STATION
In Commercial Distribution

  • 07290108670233 ()
8010290-01

  • SPECT system workstation
Single Photon Emission Computed Tomography system, stand alone processing station.
SPECTRUM DYNAMICS MEDICAL, INC
Stand Alone
Not in Commercial Distribution

  • 07290108670080 ()
8010113-01

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

  • 00884838081758 ()
453530346291

  • MRI system workstation
Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid
PDT, INC.
R978 Gross Debridement Kit
In Commercial Distribution

  • 00813677024510 ()
R978

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
SCALER, DOUBLE END, TRADE IN, OFFSET SICKLE MONTANA JACK UNIVERSAL R138 THIN BLADE, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCNMJF
In Commercial Distribution

  • 00840018647466 ()


  • Manual dental scaler, reusable
No Description
PDT, INC.
Montana 4-5 Scaler
In Commercial Distribution

  • 00813677020826 ()
R120

  • Manual dental scaler, reusable
No Description
W.H. Holden, Inc.
70-5164RK
In Commercial Distribution

  • D928705164RK0 ()


  • Periodontal curette
No Description
Roche Diagnostics GmbH
06779344190
In Commercial Distribution

  • 04015630934447 ()
06779344190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
06779336190
In Commercial Distribution

  • 04015630934416 ()
06779336190

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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