PREMIER WRIST BRACE UNIV RT

Basic Information

• Brand Name: PREMIER WRIST BRACE UNIV RT
• Primary DI: 00610570108428
• Version / Model: 08144360
• Company Name: Bird & Cronin, LLC
• Labeler DUNS: 045975349
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-20
• Public Version: 2
• Public Version Date: 2022-11-11
• Public Version Status: Update
• Public Device Record Key: 1d4497ef-7739-44b8-b6b2-99be48dcb1a2
• Distribution End Date: 2022-11-10

Device Characteristics

• Single Use: Yes
• 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: No
• 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
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45128	Wrist immobilizer, single-use	A rigid support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00610570108428	GS1