Sharn Inc

Basic Information

• Brand Name: Sharn Inc
• Primary DI: 00817518021607
• Version / Model: PPD-AB650
• Catalog Number: PPD-AB650
• Company Name: Sharn Anesthesia
• Labeler DUNS: 107996118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-10-10
• Public Version: 2
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: d907f9a0-6415-4b59-b7a5-641fb1bc3c33

Device Description

DISPOSABLE ARMBOARDS-ADULT 9inch x 4 3/4inchL 10/PK

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NOD	BOARD, ARM (WTIH COVER), NON-STERILE	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61139	Arm procedure positioner, single-use	A device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817518021607	GS1
Unit of Use	00817518022079	GS1

Customer Contacts

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