ad2ad098-f599-4b9c-a4a0-a40fab5276a8UpdatePublished42022-01-102020-08-172021-04-06Not in Commercial Distribution14897106950567PackageGS1048971069505601002021-04-06Not in Commercial DistributionBox04897106950560PrimaryGS124897106950564PackageGS11489710695056732021-04-06Not in Commercial DistributionCartonAndorate® Bite Block 66 Fr with Oxygen ConnectionGAR044686908512GA Health Company Limited1falsetruefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse34143Endoscopic bite block, basic, single-useA 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 single-use device.falseActiveMNKEndoscopic Bite Blockfalsefalse