Unite Medical®

Basic Information

• Brand Name: Unite Medical®
• Primary DI: 00850012035329
• Version / Model: Suspension Sleeve (Universal)
• Catalog Number: SS2397
• Company Name: Unite Medical, LLC
• Labeler DUNS: 117553945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-28
• Public Version: 1
• Public Version Date: 2024-01-05
• Public Version Status: New
• Public Device Record Key: 2f983067-49d3-4bed-9cbd-9075c1d99b89

Device Description

The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating.

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
ITQ	Joint, Knee, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44214	Orthosis suspension unit	A component of an orthosis that holds the orthosis to the body at various anatomical sites, e.g., the pelvis or malleolus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850012035329	GS1

Customer Contacts

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