SCOPE SAVER

Basic Information

• Brand Name: SCOPE SAVER
• Primary DI: 20653405050282
• Version / Model: 000429
• Catalog Number: 000429
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 44aeb642-f5c2-4897-8541-980fbc46126c

Device Description

CONMED Scope Saver Bite Block, 20x27mm

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: No
• 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
KTI	BRONCHOSCOPE ACCESSORY	Ear, Nose, Throat	874.4680	2

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	30653405050289	GS1	BOX	50	In Commercial Distribution
Primary	20653405050282	GS1
Unit of Use	00653405050288	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]