ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE

Basic Information

• Brand Name: ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE
• Primary DI: 03664560000152
• Version / Model: 0010-00-01
• Company Name: SARL VIPAMAT
• Labeler DUNS: 264013397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 5
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 36cff0aa-dcdc-477f-b1f0-c5b19205815c

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: No
• Has Serial Number: Yes
• 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
IQC	Wheelchair, Special Grade	Physical Medicine	890.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36261	Wheelchair wheel	A circular frame of metal and/or synthetic materials which turns on a central axle that is attached to the body of a wheelchair to enable the wheelchair to move when propelled. It comes in a variety of designs, diameters and weights, and is typically fitted with a tyre (tire); brackets for mounting the wheel onto the wheelchair may be included with the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03664560000152	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051709	000