INTENSA

Basic Information

• Brand Name: INTENSA
• Primary DI: M368748COMSW1
• Version / Model: 748-COM-SW
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 3
• Public Version Date: 2025-12-25
• Public Version Status: Update
• Public Device Record Key: 225506cf-c8b0-4ec4-8063-f1919de1ad65

Device Description

HYDRAULIC SURGICAL STOOL

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: 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
FZM	Stool, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32307	Operating room stool, manually-adjusted	A manually-operated seat intended to be occupied by a surgeon or operating room (OR) staff [e.g., surgical nurses, surgical assistants, anaesthetists] during surgical procedures as an alternative to standing. It may provide the occupier with support for the back or arms. It is typically designed with at least one manually-operated ergonomic adjustment (e.g., height and position adjustments), which is typically adjusted by a hand or foot lever, and may features wheels (castors) and breaks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M368748COMSW1	HIBCC

Customer Contacts

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