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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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Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder
No Description
GYNEX CORPORATION
16-105
In Commercial Distribution

  • GYNX161051 ()
  • GYNX16105 ()


  • Hygroscopic cervical dilator
No Description
GYNEX CORPORATION
16-104
In Commercial Distribution

  • GYNX161041 ()
  • GYNX161040 ()


  • Hygroscopic cervical dilator
No Description
GYNEX CORPORATION
16-103
In Commercial Distribution

  • GYNX161031 ()
  • GYNX161030 ()


  • Hygroscopic cervical dilator
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-10006-US
Not in Commercial Distribution

  • 03615220003990 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-05001-UN
Not in Commercial Distribution

  • 03615220003983 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15023-UN
Not in Commercial Distribution

  • 03615220003679 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15022-UN
Not in Commercial Distribution

  • 03615220003662 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15021-UN
Not in Commercial Distribution

  • 03615220003655 ()


  • Electroencephalographic ambulatory recorder
Kit contents: One dilateria, extra thick (6mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX240
Not in Commercial Distribution

  • 60888937003330 ()
  • 00888937003338 ()

  • Outer Diameter: 6 Millimeter


  • Hygroscopic cervical dilator
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