TULA TDS 1.14 GROMMET

TULA TDS 1.14 GROMMET
TULA - TDS114G

A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

No Data Available

No Data Available

Device Sterile: True

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: 00840128600047

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