ViveSole

Basic Information

• Brand Name: ViveSole
• Primary DI: 00818323025552
• Version / Model: INS1037
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-02
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: b7faf85a-307f-4f66-8658-8142882ebdad

Device Description

Gel Heel Protectors (White)

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
OHI	Orthosis, Foot Drop	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41575	Orthotic insole, prefabricated, non-antimicrobial	A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818323025559	GS1	Case	78	In Commercial Distribution
Primary	00818323025552	GS1