Ambroise

GUDID 08720299427754

Arm orthosis elbow wrist

Ambroise Holland B.V.

Custom-made upper-limb orthosis

• Primary Device ID: 08720299427754
• NIH Device Record Key: 28d13e59-d29a-4f5a-8bdb-416d89711627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambroise
• Version Model Number: Ambroise Triplemode Armorthosis (ATA)
• Company DUNS: 418298394
• Company Name: Ambroise Holland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	08720299427754 [Primary]

FDA Product Code

• IRA: Hand, External Limb Component, Mechanical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [Ambroise]

• 08720299427792: Arm orthosis with extension support
• 08720299427785: Arm orthosis for shoulder subluxation
• 08720299427778: Arm orthosis for shoulder subluxation
• 08720299427754: Arm orthosis elbow wrist
• 08720299427747: Dynamic Clubfoot orthosis
• 08720299427730: Radix prosthetic component
• 08720299427723: Knee Orthosis
• 08720299427716: Dynamic Wrist Orthosis
• 08720299427709: Dynamic Knee-Ankle-Foot Orthosis
• 08719327474440: Dynamic Wrist Orthosis
• 08719327474433: Knee Orthosis (Gen.2)
• 08719327474402: Arm orthosis with flexion support