NA

Basic Information

• Brand Name: NA
• Primary DI: 10724995165076
• Version / Model: BF452
• Catalog Number: BF452
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-04-23
• Public Version: 1
• Public Version Date: 2021-05-03
• Public Version Status: New
• Public Device Record Key: e4760f7e-f31b-430b-9556-f7810dc7c751

Device Description

The Shoulder Table Chair Cups are used in conjunction with the Shoulder Table and provide stability for the head and chin during shoulder procedures.

Device Characteristics

• Single Use: Yes
• 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: No
• 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
HSS	HALTER, HEAD, TRACTION	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63966	Medical table restraint anchor	A device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00724995165079	GS1
Primary	10724995165076	GS1

Customer Contacts

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