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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® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173230038) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 3 (1mL)
Not in Commercial Distribution

  • 07640173230038 ()
  • 07640173230045 ()
940008

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery unit, system-based
90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit.
Beyond Air, Inc.
90007
In Commercial Distribution

  • B882900071 ()
  • B882900070 ()
  • B882900072 ()


  • Nitric oxide delivery unit, system-based
90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery unit, system-based
Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution

  • M2138067M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.
SAIMA GLOBAL FARMA S.L.
Gel 1 mL Syringe
In Commercial Distribution

  • 08437027710087 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution

  • 00810335020167 ()


  • Infusion pump programmer
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD33
In Commercial Distribution

  • 04260182521687 ()

  • Outer Diameter: 33 Millimeter
37ASD33

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD30
In Commercial Distribution

  • 04260182521670 ()

  • Outer Diameter: 30 Millimeter
37ASD30

  • Cardiac defect occluder
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