VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00810041981776
• Version / Model: SUP2023
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 43b9bba8-68ba-4ec5-95c7-215d47f95016

Device Description

Trigger Finger Splint

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
62978	Padded stays splint, single-use	A padded device designed to immobilize and protect an injured body extremity (arm or leg) during the healing process. It is typically in the form of a preshaped rigid mould (with padding) intended to be held in place with straps/bandages (not included); it is not primarily intended for use in an emergency setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041981773	GS1	Case	100	In Commercial Distribution
Primary	00810041981776	GS1