Vive

Basic Information

• Brand Name: Vive
• Primary DI: 00810041980083
• Version / Model: SUP2024RGRYXL
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-18
• Public Version: 1
• Public Version Date: 2023-10-26
• Public Version Status: New
• Public Device Record Key: 6a957535-475a-4d51-9d94-485ad932bcdf

Device Description

Wrist Immobilizer (Right) Grey XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
IPG	Shoe, Cast	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12102	Wrist immobilizer, reusable	A rigid support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041980080	GS1	Case	45	In Commercial Distribution
Primary	00810041980083	GS1