TULA EARPLUG SIZERS

TULA EARPLUG SIZERS
TULA - EPSZRSET

A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable 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: 00840128600160

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