ALLEN

Basic Information

• Brand Name: ALLEN
• Primary DI: 00615521014766
• Version / Model: 900111
• Catalog Number: F-NHRSKY
• Company Name: ALLEN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 147805894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-31
• Public Version: 1
• Public Version Date: 2023-06-08
• Public Version Status: New
• Public Device Record Key: 9e64b2ba-1b84-4d9d-8e2d-f21b674008c3

Device Description

Narrow Head Rest, Skytron

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: 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63229	Operator armrest	A preformed frame designed to provide support for a healthcare provider's hands/wrist/arm during a medical procedure. It is attached to an appropriate procedure table (e.g., operating, treatment) or another supporting device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521014766	GS1

Customer Contacts

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