Vive

Basic Information

• Brand Name: Vive
• Primary DI: 00810041988232
• Version / Model: SUP2099L
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: d092b294-ded9-4e4a-a50d-f17f1d095406

Device Description

Advanced Thumb Brace (Left)

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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41461	Wrist/hand/metacarpophalangeal joint extension orthosis	An externally applied orthopaedic appliance or apparatus designed to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles). The device has an outrigger (a projecting support) to assist in the extension of the thumb. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041988239	GS1	Case	40	In Commercial Distribution
Primary	00810041988232	GS1