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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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Transducer Replicas
Envoy Medical Corporation
1510
In Commercial Distribution

  • 00812282020306 ()

  • Surgical Replica of Model 7010 Sensor
  • Surgical Replica of Model 7510 Driver
901510-002

  • Fully-implantable middle ear implant system
Cable used for connection of Probe unit with Nevisense.
Scibase AB
730-0009
In Commercial Distribution

  • 07350094440095 ()
730-0009

  • Neoplasm electrical impedance spectrometer
3100B Disposables Kit, Box of 4 / F&P 850
VYAIRE MEDICAL, INC.
29028-016
Not in Commercial Distribution

  • 50190752159868 ()
29028-016

  • Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / F&P 730
VYAIRE MEDICAL, INC.
29028-015
Not in Commercial Distribution

  • 50190752159851 ()
29028-015

  • Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / F&P 850
VYAIRE MEDICAL, INC.
11744-730K
In Commercial Distribution

  • 50190752157567 ()
11744-730K

  • Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / F&P 850
VYAIRE MEDICAL, INC.
11744-850K
In Commercial Distribution

  • 50190752155150 ()
11744-850K

  • Ventilator breathing circuit, single-use
The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.
Carl Zeiss Meditec AG
MEL 80
In Commercial Distribution

  • 04049471000221 ()

  • Weight: 260 Kilogram
  • LxWxH: 1.55m x 0.80m x1.49m


  • Ophthalmic excimer laser system
The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw. T-Handle 5mm Socket M9 Guide Pin Rescue Drill Bit Holder Drill / Torx Guide Allen Key 2.5 mm
Integrum AB
2533
In Commercial Distribution

  • 07340152102027 ()


  • Internal-external leg prosthesis osseointegration bar
VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. VISCO-3 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. VISCO-3 is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
00-1111-001-03
In Commercial Distribution

  • 04987541301314 ()
  • 14987541301311 ()
00-1111-001-03

  • Synovial fluid supplementation medium
SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium
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