MOUTHPIECE

MOUTHPIECE - MA-651

A device intended to be inserted into a patient's mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient's natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• High-level Disinfectant
• Ethylene Oxide

Code: MNK

Device Name: Endoscopic Bite Block

Device Class: 1

Physical State: Bite block

Definition: To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Placed into mouth over teeth.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Mouth

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170438240

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