TULA EARSET SPARE
TULA - ESLNG
Device Description
An assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a disposable, battery-powered, current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QJA
Device Name: Tympanostomy Tube Delivery Product With Drug
Device Class: 3
Physical State: This product is comprised of a tympanostomy tube, tympanostomy tube delivery system, anesthesia drug, and an iontophoretic local anesthesia delivery system. This product includes a mechanical device that rapidly creates a myringotomy and places the tympanostomy tube across the tympanic membrane after the anesthetic drug numbs the tympanic membrane.
Definition: Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Submission Type ID: 2
Review Panel: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A local anesthetic system delivers anesthetic drug and electric current to provide sufficient anesthesia to place a tympanostomy tube. A tympanostomy tube delivery device is then used to rapidly place the tympanostomy tube across the tympanic membrane.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Tympanic membrane
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 20840128600201
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00840128600207
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BX
Device Id: 00840128600207
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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