DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756163569
• Version / Model: AD9001-HK
• Catalog Number: AD9001-HK
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-03
• Public Version: 1
• Public Version Date: 2021-08-11
• Public Version Status: New
• Public Device Record Key: 2164aa90-8da6-44c2-8d77-d9c1edf48181

Device Description

HIP KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILW	ADAPTOR, GROOMING	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31052	Assistive dressing/undressing hook/stick	A device typically in the form of a hook with a handle, or a long stick with a handle and a hook at the distal end, designed to be used by a person with a disability to hook, fix, or grasp a garment to manoeuvre and adjust it while dressing or undressing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756163569	GS1

Customer Contacts

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