Sharn Inc

Basic Information

• Brand Name: Sharn Inc
• Primary DI: 00817518021386
• Version / Model: 41487
• Catalog Number: 41487
• Company Name: Sharn Anesthesia
• Labeler DUNS: 107996118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-10-10
• Public Version: 4
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 3cd0727d-e8f6-439a-ac7b-1528a5c1f38b

Device Description

Safe-Soak Endo Sponge Flat Sponge/Dispenser Box PK50

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61965	Medical device cleaning sponge/set	A hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817518021386	GS1
Unit of Use	00817518021812	GS1

Customer Contacts

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