TULA CONTROL UNIT SPARE

TULA CONTROL UNIT SPARE
TULA - IOCNTRL

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00840128600146

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