Vivesole

GUDID 10818323026839

High Heel Insoles

VIVE HEALTH LLC

Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial

• Primary Device ID: 10818323026839
• NIH Device Record Key: 03f68122-bcc8-4c11-8b2a-2e54470e2642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivesole
• Version Model Number: INS1009
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818323026832 [Primary]
GS1	10818323026839 [Package]; Contains: 00818323026832; Package: Case [90 Units]; In Commercial Distribution

FDA Product Code

• KYS: Insoles, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [Vivesole]

• 10818323026761: INS1006L
• 10818323026938: Men's Silicone Gel Heel Cup Blue Small
• 10818323026853: Heel Cup Small
• 10818323026846: Heel Cup Large
• 10818323027249: Women's Silicone Gel Heel Cup Pink Small
• 10818323027096: Hammer Toe and Budin Splint
• 10818323027089: Women's Silicone Gel Heel Cup Pink Large
• 10818323027027: Vivesole Gel Insole Women's
• 10818323027010: Vivesole Gel Insole Men's
• 10818323027003: Plantar Plus XSmall
• 10818323026990: Plantar Plus XLarge
• 10818323026983: Plantar Plus Small
• 10818323026921: Plantar Plus Medium
• 10818323026914: Plantar Plus Large
• 10818323026891: Shock gel 3/4 Men's
• 10818323026839: High Heel Insoles
• 10818323026808: Vivesole 3/4 XSmall
• 10818323026792: Vivesole 3/4 XLarge
• 10818323026785: Vivesole 3/4 Small
• 10818323026778: Vivesole 3/4 Medium
• 10818323026754: Vivesole Full XSmall
• 10818323026730: Vivesole Full XLarge
• 10818323026723: Vivesole Full Small
• 10818323026556: Vivesole Full Medium
• 10818323026549: Vivesole Full Large
• 10818323023050: Metatarsal Pad with Toe Ring (New)
• 10818323020783: Memory Foam Insoles (Large)
• 10818323020776: Memory Foam Insoles (Medium)
• 10818323020240: FELT ARCH PADS WHITE
• 10810041988956: Arch Support Gel Insoles
• 10810041989311: Gel Metatarsal Sleeve
• 10850041211753: Gel Metatarsal Sleeves (Medium)
• 10810041989045: Gel Metatarsal Sleeves (Large)
• 10810041989038: Gel Metatarsal Sleeves (Small)
• 10818323025559: Gel Heel Protectors (White)
• 10810113570225: Gel Heel Protectors (Black)
• 00810041983374: Memory Foam Insole (Large)
• 10810041983364: Memory Foam Insoles (Medium)
• 10810041983357: Memory Foam Insoles (Small)
• 10810041989403: Heavy Duty Gel Insole (Black) XL
• 10810041989397: Heavy Duty Gel Insole (Black) Large
• 10810041989380: Heavy Duty Gel Insole (Black) Medium
• 10810041989373: Heavy Duty Gel Insole (Black) Small
• 10810041989199: Heavy Duty Gel Insole (Blue) XL
• 10810041988925: Heavy Duty Gel Insole (Blue) Medium
• 10810041988918: Heavy Duty Gel Insoles (Blue) Large
• 10810041988901: Heavy Duty Gel Insole (Blue) Small
• 10810113572465: Carbon Fiber Insole (Small)
• 10810113572533: Carbon Fiber Insoles (5XL)
• 10810113572526: Carbon Fiber Insoles (4XL)