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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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CLARINET - 08054187380471

MIDDLE EAR ANALYZER. Clarinet Basic is a clinical middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, acoustic reflex decay, acoustic reflex latency, Eustachian Tube Function (ETF) both for intact and perforated tympanic membrane. Clarinet Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
CLARINET BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380471 ()
10518

  • Impedance audiometer

FLUTE - 08054187380457

MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. Flute HF has, in addition, an integrated thermal printer.
INVENTIS SRL
FLUTE HF WITH PRINTER
In Commercial Distribution

  • 08054187380457 ()
10410

  • Impedance audiometer

VIOLA - 08054187380433

MIDDLE EAR ANALYZER / AUDIOMETER. Viola Plus is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically, reflex test decay; pure tone and speech audiometry using air and bone conduction. Viola Plus with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
VIOLA PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380433 ()
10375

  • Impedance audiometer
  • Tone audiometer

VIOLA - 08054187380419

MIDDLE EAR ANALYZER / AUDIOMETER. Viola Basic is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically; pure tone audiometry using air and bone conduction. Viola Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
VIOLA BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380419 ()
10344

  • Impedance audiometer
  • Tone audiometer

FLUTE - 08054187380280

MIDDLE EAR ANALYZER. Flute Plus is a middle ear analyzer, capable of performing: tympanometry, and acoustic reflex tests in sequence and automatically, manual tympanometry, the Eustachian tube function test for intact eardrums, the reflex decay test and the facility of conducting the acoustic reflex test in manual mode. In addition, it allows to adjuste manually the pressure setting used for reflex tests. Flute Plus with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
FLUTE PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380280 ()
10341

  • Impedance audiometer

FLUTE - 08054187380266

MIDDLE EAR ANALYZER. Flute Basic is a screening middle ear analyzer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically. Flute Basic with printer has, in addition, an integrated thermal printer.
INVENTIS SRL
FLUTE BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380266 ()
10338

  • Impedance audiometer

PIANO - 08054187380112

AUDIOMETER. Piano Plus is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry, Bekesy and MLD tests. Piano Plus with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
PIANO PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380112 ()
10165

  • Tone audiometer

PIANO - 08054187380099

AUDIOMETER. Piano Basic is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and supra-threshold tests. Piano Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
PIANO BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380099 ()
10164

  • Tone audiometer

HARP - 08054187380075

AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests. Harp Plus with Printer has, in addtion, an integrated thermal printer.
INVENTIS SRL
HARP PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380075 ()
10163

  • Tone audiometer

HARP - 08054187380051

AUDIOMETER. Harp Basic is an advanced diagnostic audiometer, capable of performing speech and pure-tone audiometry, via air conduction, bone conduction, and free field. Harp Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
HARP BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380051 ()
10162

  • Tone audiometer

Orthopaedic Surgical Instruments - 08052990977727

No Description
CITIEFFE SRL
Cannula with handle ø13.5mm
In Commercial Distribution

  • 08052990977727 ()
VT-96410

  • Surgical drill guide, reusable

Orthopaedic Surgical Instruments - 08052990976867

No Description
CITIEFFE SRL
Cannula with handle ø16mm
In Commercial Distribution

  • 08052990976867 ()
VT-96415

  • Surgical drill guide, reusable

MIR - 08052990321629

PC based spirometer for lung function testing
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MiniSpir spirometer with cable
In Commercial Distribution

  • 08052990321629 ()


  • Expiratory peak flow meter, digital

EvaCare Pessary - 08519520070025

Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele.
PERSONAL MEDICAL CORP.
Cube Pessary with Drain
In Commercial Distribution

  • 08519520070025 ()

  • Width: 25 Millimeter
  • Width: 29 Millimeter
  • Width: 33 Millimeter
  • Width: 37 Millimeter
  • Width: 41 Millimeter
  • Width: 45 Millimeter
  • Width: 50 Millimeter
  • Width: 56 Millimeter
  • Width: 63 Millimeter
  • Width: 70 Millimeter
  • Width: 75 Millimeter
CUD

  • Bladder-supporting pessary

EvaCare Pessary - 08519520070018

Pessary, Vaginal. Dish Pessary is used to relieve stress incontinence and minor degrees of prolapse.
PERSONAL MEDICAL CORP.
Dish Pessary with Support
In Commercial Distribution

  • 08519520070018 ()

  • Width: 85 Millimeter
  • Width: 80 Millimeter
  • Width: 75 Millimeter
  • Width: 70 Millimeter
  • Width: 65 Millimeter
  • Width: 60 Millimeter
  • Width: 55 Millimeter
  • Width: 50 Millimeter
DSHS

  • Bladder-supporting pessary

FLUFSAN - 08015013360906

Waterproof bed mattress cover 80X180 cm with wings , single-use 15 PIECES PER BAG
EUROPROSAN SPA
Flufsan 80X180 with wings
In Commercial Distribution

  • 08015013360906 ()
360906

  • Absorbent underpad, non-antimicrobial, single-use

REVISION Hip - 08033390112871

Trial Neck with Screw H=110mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112871 ()

  • H=110mm
9038.10.710

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112864

Trial Neck with Screw H=100mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112864 ()

  • H=100mm
9038.10.700

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112857

Trial Neck with Screw H=90mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112857 ()

  • H=90mm
9038.10.690

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112840

Trial Neck with Screw H=80mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112840 ()

  • H=80mm
9038.10.680

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112833

Trial Neck with Screw H=70mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112833 ()

  • H=70mm
9038.10.670

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112826

Trial Neck with Screw H=60mm
LIMACORPORATE SPA
Trial Neck with Screw
In Commercial Distribution

  • 08033390112826 ()

  • H=60mm
9038.10.660

  • Femoral stem prosthesis trial

REVISION Hip - 08033390112819

Trial Neck with Screw H=50mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390112819 ()

  • H=50mm
9038.10.650

  • Femoral stem prosthesis trial

PHYSICA Instrument Set - 08033390102926

EM Tibial Guide with Clamp
LIMACORPORATE SPA
Tibial Guide with Clamp
In Commercial Distribution

  • 08033390102926 ()
9065.20.061

  • Orthopaedic prosthesis implantation positioning instrument, reusable

REVISION Hip - 08033390046800

Trial Neck with Screw h=90mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390046800 ()

  • h=90mm
9038.10.190

  • Femoral stem prosthesis trial

REVISION Hip - 08033390046794

Trial Neck with Screw h=80mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390046794 ()

  • h=80mm
9038.10.180

  • Femoral stem prosthesis trial

REVISION Hip - 08033390046787

Trial Neck with Screw h=70mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390046787 ()

  • h=70mm
9038.10.170

  • Femoral stem prosthesis trial

REVISION Hip - 08033390046770

Trial Neck with Screw h=110mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390046770 ()

  • h=110mm
9038.10.210

  • Femoral stem prosthesis trial

REVISION Hip - 08033390046763

Trial Neck with Screw h=100mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390046763 ()

  • h=100mm
9038.10.200

  • Femoral stem prosthesis trial

REVISION Hip - 08033390039512

Trial Neck with Screw h=60mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390039512 ()

  • h=60mm
9038.10.160

  • Femoral stem prosthesis trial

REVISION Hip - 08033390039505

Trial Neck with Screw h=50mm
LIMACORPORATE SPA
Trial Neck With Screw
In Commercial Distribution

  • 08033390039505 ()

  • h=50mm
9038.10.150

  • Femoral stem prosthesis trial

AMPatch Stoma Cover - 00838234005993

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
N-2 with Oval Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234005993 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234005566

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MFFE with 1" Hole
In Commercial Distribution

  • 00838234009984 ()
  • 00838234005566 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234005078

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
F-4 with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234005078 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234005016

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a hole located on one end of the stoma cover, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
G-23 with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234005016 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234004958

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
G-4 with Rectangular Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234004958 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234004767

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
LGR with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234004767 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234004699

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
D with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234004699 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234002206

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MLGR with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234002206 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234002060

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
LNR with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234002060 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234002008

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MG-3 with Rectangular Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234002008 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001988

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MLGR with Oval Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001988 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001971

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MG-3 with Oval Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001971 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001865

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
MP with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001865 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001803

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
DE with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001803 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001629

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
GG-3 with Rectangular Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001629 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001612

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
G-2 with Rectangular Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001612 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001544

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
F-2 with Oval Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001544 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001469

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
F-3 with Rectangular Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001469 ()


  • Absorbent stomal dressing

AMPatch Stoma Cover - 00838234001414

Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device.
Austin Medical Products, Inc.
F-3 with 1" Hole
In Commercial Distribution

  • 00838234009991 ()
  • 00838234001414 ()


  • Absorbent stomal dressing
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