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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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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
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
PLNG STATION 9734048 STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048
In Commercial Distribution

  • 00613994532398 ()


  • Stereotactic surgery system workstation
PLNG STATION 9734669R RWK S7
MEDTRONIC NAVIGATION, INC.
9734669R
In Commercial Distribution

  • 00613994792921 ()


  • Stereotactic surgery system workstation
PLNG STATION 9734048R STEALTHSTATION S7
MEDTRONIC NAVIGATION, INC.
9734048R
In Commercial Distribution

  • 00643169777316 ()


  • Stereotactic surgery system workstation
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
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
NEPHROS, INC.
TQE0.005-10HP3E
In Commercial Distribution

  • 10868277000447 ()
  • 00868277000440 ()
  • 20868277000444 ()


  • Haemodialysis system dialysate pyrogen filter
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
Filter for clean dialysate and water
NIPRO MEDICAL CORPORATION
CF+609N
In Commercial Distribution

  • 40383790008868 ()
  • 00383790008860 ()


  • 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
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.
0-00116-001
In Commercial Distribution

  • 10815411020106 ()


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

  • 07290108670233 ()
8010290-01

  • SPECT system workstation
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