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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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Diacap® - 04046963178116

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

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • 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

StealthStation® AXIEM™ System - 00613994109477

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

  • 00613994109477 ()


  • Stereotactic surgery system workstation

PDT, Inc. - 00813677025210

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

PDT, Inc. - 00813677024510

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

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-120V-S - 10815411020823

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

  • 10815411020823 ()


  • CT system workstation

OPTION, NL4X00 WS-240V - 10815411020816

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

  • 10815411020816 ()


  • CT system workstation

OPTION, NL4X00 WS-240V-S - 10815411020809

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

  • 10815411020809 ()


  • CT system workstation

OPTION, WS CART NL4000 - 10815411020229

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

  • 10815411020229 ()


  • CT system workstation
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