STRADIS

Basic Information

• Brand Name: STRADIS
• Primary DI: M7522800461
• Version / Model: 280-046
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 3
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: f9622f9c-1b59-4254-8c59-0af99665faa6
• Distribution End Date: 2023-02-02

Device Description

NON-STERILE SEPARATE TABLE CUSHION

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWG	Surgical Table Cushion	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41141	Arm cushion	A soft pillow or pad used to provide support and comfort to the user's arm, typically during the treatment and/or prevention of musculoskeletal or circulatory disorders (e.g., muscle sprain/strain, lymphoedema). The device may be used to support various areas of the arm (i.e., wrist, elbow, or shoulder).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7522800461	HIBCC

Customer Contacts

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