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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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MAR0Fuse Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse1cc
Not in Commercial Distribution

  • M896MAR0FUSE1CC1 ()

  • Total Volume: 1 Milliliter


  • Bone matrix implant, human-derived
MAR0FUSE Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse10cc
Not in Commercial Distribution

  • M896MAR0FUSE10CC1 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, human-derived
The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance. Excellent to sleep with while wearing the device.
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil II,10A,Digital,Pair
In Commercial Distribution

  • 00089518000504 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance.
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil II,10A,Digital,Right
In Commercial Distribution

  • 00089518000498 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance.
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil II,10A,Digital,Left
In Commercial Distribution

  • 00089518000481 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Pair
In Commercial Distribution

  • 00089518000474 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Right
In Commercial Distribution

  • 00089518000467 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Left
In Commercial Distribution

  • 00089518000450 ()


  • Air-conduction tinnitus masker, in-the-ear
The Tinnitus custom device utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing design. Designed for patients that suffer from Tinnitus to ease ringing in the ear.
GENERAL HEARING INSTRUMENT, INC.
Tinnitus,Custom,Pair
In Commercial Distribution

  • 00089518000801 ()


  • Air-conduction tinnitus masker, in-the-ear
The Tinnitus custom device utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing design. Designed for patients that suffer from Tinnitus to ease ringing in the ear.
GENERAL HEARING INSTRUMENT, INC.
Tinnitus,Custom,Right
In Commercial Distribution

  • 00089518000795 ()


  • Air-conduction tinnitus masker, in-the-ear
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