Ergostyle HYLO

Basic Information

• Brand Name: Ergostyle HYLO
• Primary DI: 00850020142170
• Version / Model: EH9540
• Company Name: PIVOTAL HEALTH SOLUTIONS, INC.
• Labeler DUNS: 826316098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-27
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: c220e206-51cb-4edf-935a-370591a41ce6

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: 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
INQ	Table, Powered	Physical Medicine	890.3760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31362	Examination/treatment table, line-powered	A mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850020142170	GS1