NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995203283
• Version / Model: ShroudGuard
• Catalog Number: BF068
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 1
• Public Version Date: 2021-04-12
• Public Version Status: New
• Public Device Record Key: fc7e59fb-1ffc-4235-b8be-72dd9445d93f

Device Description

The ShroudGuard Surround for 4000 Series Surgical Tables protects the OR table base on four sides with a sturdy, metal structure that prevents accidental damage caused by the pedestal shroud cladding being lowered onto objects placed near or against the pedestal.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GDC	TABLE, OPERATING-ROOM, ELECTRICAL	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65222	Operating table pedestal protector	A device in the form of a fence/surround intended to protect the pedestal/cladding of an operating table from direct physical damage. It is a multi-piece shield/guard which clips together around the perimeter of the base of the pedestal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995203283	GS1

Customer Contacts

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