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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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Fluency® Endovascular Stent Graft - 04049519008042

FLUENCY® PLUS Endovascular Stent Graft 6 mm x 60 mm (117 cm delivery system)
Bard Peripheral Vascular, Inc.
FEL06060
In Commercial Distribution

  • 04049519008042 ()

  • Implant Diameter,6 Millimeter
  • Catheter Length,117 Centimeter
  • Implant Length,60 Millimeter
FEL06060

  • Central/peripheral venous endovascular stent-graft

Fluency® Endovascular Stent Graft - 04049519008035

FLUENCY® PLUS Endovascular Stent Graft 6 mm x 40 mm (117 cm delivery system)
Bard Peripheral Vascular, Inc.
FEL06040
In Commercial Distribution

  • 04049519008035 ()

  • Implant Diameter,6 Millimeter
  • Catheter Length,117 Centimeter
  • Implant Length,40 Millimeter
FEL06040

  • Central/peripheral venous endovascular stent-graft

Belotero Balance - M2138700M05

Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.
MERZ NORTH AMERICA, INC.
8700M0
Not in Commercial Distribution

  • M2138700M05 ()

  • Total Volume: 1 Milliliter


  • Dermal tissue reconstructive material, microbe-derived

RESTYLANE REFYNE - 08437027710094

RESTYLANE REFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.
SAIMA GLOBAL FARMA S.L.
Gel 1 mL Syringe
In Commercial Distribution

  • 08437027710094 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Artificial Iris with Fiber - 04049154000012

The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95001
In Commercial Distribution

  • 04049154000012 ()

  • Outer Diameter: 12.8 Millimeter
00095001

  • Implantable iris prosthesis

Inspire - 00810098650038

The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-029-001
In Commercial Distribution

  • 00810098650038 ()
2740S

  • Implantable sleep apnoea treatment system, respiration-sensing

Intacs Corneal Implants - 00866304000104

An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI
In Commercial Distribution

  • 00866304000104 ()


  • Intracorneal ring segment
  • Intracorneal ring

NA - 10886704043768

FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000035

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100
Not in Commercial Distribution

  • 10868866000032 ()
  • 00868866000035 ()
Sterile-C100

  • Electrode conductive skin pad, single-use

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000028

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Zoll adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100-Zoll
Not in Commercial Distribution

  • 10868866000025 ()
  • 00868866000028 ()
Sterile-C100-Zoll

  • Electrode conductive skin pad, single-use
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