Vive Sole

GUDID 10818323027232

Men's Silicone Gel Heel Cup Blue Large

VIVE HEALTH LLC

Orthotic insole, prefabricated

• Primary Device ID: 10818323027232
• NIH Device Record Key: 3367a91c-6b0a-4a72-8270-cf51a2000fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive Sole
• Version Model Number: INS1023ML
• 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	00818323027235 [Primary]
GS1	10818323027232 [Package]; Contains: 00818323027235; Package: Case [100 Units]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-26
• Device Publish Date: 2019-03-18

Devices Manufactured by VIVE HEALTH LLC

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• 10810113578054 - Vive: 2024-09-16 Elbow Compression Sleeve (Medium)
• 10810113578061 - Vive: 2024-09-16 Elbow Compression Sleeve (Large)
• 10810113578078 - Vive: 2024-09-16 Elbow Compression Sleeve (XL)
• 10810113578221 - Vive: 2024-09-16 Toilet Safety Frame with Handles
• 10810113578337 - CoreTech: 2024-09-16 Quick Lace Ankle Brace (XS)