CooreTech

GUDID 10810113576388

760 ROM Elbow Brace (Right)

VIVE HEALTH LLC

Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer Elbow immobilizer

• Primary Device ID: 10810113576388
• NIH Device Record Key: 4ece384d-11e2-4533-9ded-ce6667435607
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CooreTech
• Version Model Number: SUP3058BLKR
• 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	00810113576381 [Primary]
GS1	10810113576388 [Package]; Contains: 00810113576381; Package: Case [15 Units]; In Commercial Distribution

FDA Product Code

• IQI: Orthosis, Limb Brace

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [CooreTech]

• 10810113576388: 760 ROM Elbow Brace (Right)
• 10810113576371: 760 ROM Elbow Brace (Left)