NA

Basic Information

• Brand Name: NA
• Primary DI: 15060797551101
• Version / Model: BD050-HCS
• Catalog Number: BD050-HCS
• Company Name: David Scott Company
• Labeler DUNS: 073814568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: 97d7ecf1-8be3-44e1-880f-85668df73a35

Device Description

Disposable Head and Chin Strap to be used with shoulder chairs from a variety of vendors. These are deisgned to reduce the risk of head movement during shoulder surgery when restrained in a surgical beach chair. The straps are a soft handed loop material that will mate with a hook material on the head restraint. A pocket is designed to craddle the chin,. Each kit has 2 straps, 1 for the forehead, and 1 for the chin. they are 22" long and 2" Wide.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62482	Limb/torso/head restraint, reusable	A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060797551101	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch
Length	22	Inch
Height	.25	Inch