andorate® Bite Block 66Fr with Strap and Tooth Protector

Basic Information

• Brand Name: andorate® Bite Block 66Fr with Strap and Tooth Protector
• Primary DI: 04897106952939
• Version / Model: SDPC0210F
• Company Name: GA Health Company Limited
• Labeler DUNS: 686908512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-10
• Public Version: 3
• Public Version Date: 2022-03-02
• Public Version Status: Update
• Public Device Record Key: bf191592-d69e-4bd9-b104-0f02160ea5e6
• Distribution End Date: 2020-12-17

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNK	Endoscopic Bite Block	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34143	Endoscopic bite block, basic, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14897106952936	GS1	Box	100	Not in Commercial Distribution	2020-12-17
Primary	04897106952939	GS1
Package	24897106952933	GS1	Carton	3	Not in Commercial Distribution	2020-12-17