Vivesole

GUDID 10818323026761

VIVE HEALTH LLC

Orthotic insole, prefabricated, antimicrobial

• Primary Device ID: 10818323026761
• NIH Device Record Key: 43612d64-178b-4bfc-86fa-889facf09fea
• Commercial Distribution Discontinuation: 2019-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vivesole
• Version Model Number: INS1006L
• 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	00818323026764 [Primary]
GS1	10818323026761 [Package]; Contains: 00818323026764; Package: Case [50 Units]; Discontinued: 2019-04-05; Not in Commercial Distribution

FDA Product Code

• KNP: Orthosis, Corrective Shoe

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-08
• 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)