Slide-on®Endosheath®

Basic Information

• Brand Name: Slide-on®Endosheath®
• Primary DI: 20613994657804
• Version / Model: 225601
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-04-09
• Public Version: 7
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 15e6ad14-1ed2-4825-8584-a42e5b1bd094

Device Description

SHEATH 225601 20PK SLIDE-ON ENT-5000

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	20613994657804	GS1
Unit of Use	00613994657800	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012543	000