Ambroise

Basic Information

• Brand Name: Ambroise
• Primary DI: 08720299427716
• Version / Model: ADPO
• Company Name: Ambroise Holland B.V.
• Labeler DUNS: 418298394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: a28ba827-0280-4b36-ab63-cf75daeaced0

Device Description

Dynamic Wrist Orthosis

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: 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
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41458	Wrist orthosis	A prefabricated (non-customized) externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720299427716	GS1