SLIDE-ON® ENDOSHEATH®

Basic Information

• Brand Name: SLIDE-ON® ENDOSHEATH®
• Primary DI: 20763000089652
• Version / Model: 224501
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-07-07
• Public Version: 6
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 4fc12238-57d4-4041-a845-9485a470783f

Device Description

SHEATH 224501 20PK OLYMPUS ENF-V

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (flexible or rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44711	Optical medical device procedural cover	A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20763000089652	GS1
Unit of Use	00763000089658	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012543	000