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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 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 Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Grey,Pair
In Commercial Distribution

  • 00089518000320 ()


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

  • 00089518000313 ()


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

  • 00089518000306 ()


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

  • 00089518000290 ()


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

  • 00089518000283 ()


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

  • 00089518000276 ()


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

  • 00089518000269 ()


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

  • 00089518000252 ()


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

  • 00089518000245 ()


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

  • 00089518000238 ()


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

  • 00089518000221 ()


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

  • 00089518000214 ()


  • Air-conduction tinnitus masker, out-of-ear
UNIVERSAL S/I (STRAIGHT HANDLE), STRAIGHT GRIP SUCTION/IRRIGATION INSTRUMENT
Conmed Corporation
60-6020-115
In Commercial Distribution

  • 20653405011825 ()
  • 30653405011822 ()
  • 00653405011821 ()
60-6020-115

  • Surgical irrigation/aspiration handpiece control valve
UNIVERSAL S/I (PISTOL GRIP HANDLE), SUCTION/IRRIGATION INSTRUMENT
Conmed Corporation
60-6020-100
In Commercial Distribution

  • 20653405011795 ()
  • 30653405011792 ()
  • 00653405011791 ()
60-6020-100

  • Surgical irrigation/aspiration handpiece control valve
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724120234S1 ()
120-234S

  • Malar prosthesis
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724120224S1 ()
120-224S

  • Malar prosthesis
Malar Implant
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724120214S1 ()
120-214S

  • Malar prosthesis
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25190119162016 ()
  • 20190119016666 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25190119016036 ()
  • 25190119165000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25180809051010 ()
  • 05251808091010 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 25180809000001 ()
  • 00251808090001 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
CLASSYS Inc.
VLMC02501
Not in Commercial Distribution

  • 08800016902730 ()


  • Radio-frequency skin contouring system applicator tip
Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10352
In Commercial Distribution

  • 05055273216509 ()
SR10352

  • Multiple-type blood-borne pathogen antibody/antigen IVD, control
No Description
MEDIVANCE INSTRUMENTS LIMITED
MK5
In Commercial Distribution

  • 05060209580012 ()
I/MAC8502F /I/MAC8503F /I/MAC8508F

  • Dental abrasive air jet system
DRH ORTHOPEDIC I AND D PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0151234C
In Commercial Distribution

  • 10889942214419 ()
DYNJ0151234C

  • General surgical procedure kit, non-medicated, single-use
Kit 3 electrodes for Cefaly I
Cefaly Technology SPRL
11101
In Commercial Distribution

  • 05425018850044 ()
  • 05425018850198 ()


  • Craniofacial analgesia electrical stimulator
KOVA TROL I (4 x 15mL)
KOVA INTERNATIONAL, INC.
4263
In Commercial Distribution

  • 00850015517143 ()
4263

  • Urine sediment IVD, control
20-30 COMFORT PANTY CT NAVY I
MEDI MANUFACTURING, INC.
46931
In Commercial Distribution

  • 00636257104842 ()


  • Compression/pressure sock/stocking, single-use
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