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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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"One box of RHA® 4 Mepi contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233411) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 Mepi - TSK - US
In Commercial Distribution

  • 07640173233411 ()
  • 07640173233480 ()
940033

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
No Description
OPHTHAMIC SOLUTION, INC.
Intraocular Lens
In Commercial Distribution

  • 00840244500009 ()


  • Posterior-chamber intraocular lens, pseudophakic
An electronic device used to program the ASSURE system and assist in patient fitting and training
Kestra Medical Technologies, Inc.
80041-002
In Commercial Distribution

80041-002

  • Wearable defibrillation system defibrillator
The ASSURE Wearable Cardioverter Defibrillator System
Kestra Medical Technologies, Inc.
80014-002
In Commercial Distribution

80014-002

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
In Commercial Distribution

80008-004

  • Wearable defibrillation system defibrillator
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 Fiber Free model is suitable for sutureless implant techniques or can be sutured. 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
95002
In Commercial Distribution

  • 04049154000029 ()

  • Outer Diameter: 12.8 Millimeter
00095002

  • Implantable iris prosthesis
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
TriVisc
Avanos Medical, Inc.
50653-0006-04
In Commercial Distribution

  • 10193493000767 ()
  • 00193493000760 ()

  • 25 MG / 2.5 mL
50653-0006-04

  • Synovial fluid supplementation medium
GenVisc 850
Avanos Medical, Inc.
50653-0006-01
In Commercial Distribution

  • 10193493000750 ()
  • 00193493000753 ()

  • 25 MG / 2.5 mL
50653-0006-01

  • Synovial fluid supplementation medium
No Description
Q-Med AB
Gel 1 mL Syringe
In Commercial Distribution

  • 00302995969141 ()


  • Dermal tissue reconstructive material, microbe-derived
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