ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE

GUDID 03664560000152

SARL VIPAMAT

Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel Wheelchair wheel

• Primary Device ID: 03664560000152
• NIH Device Record Key: 36cff0aa-dcdc-477f-b1f0-c5b19205815c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE
• Version Model Number: 0010-00-01
• Company DUNS: 264013397
• Company Name: SARL VIPAMAT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664560000152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051709

FDA Product Code

• IQC: Wheelchair, Special Grade

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-20
• Device Publish Date: 2017-05-26

Devices Manufactured by SARL VIPAMAT

• 03664560000145 - APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST: 2024-03-05
• 03664560000176 - APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST: 2024-03-05
• 03664560000152 - ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE: 2020-08-20
• 03664560000152 - ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLE: 2020-08-20