Epikut Plus ILHE 5011N

GUDID 07899995273581

IMPLANTE HE Ø5,0 X 11,5MM

Sin Sistema de Implante Nacional S/A

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• Primary Device ID: 07899995273581
• NIH Device Record Key: 23ff94bf-4b14-4c11-afb0-129ab42ea126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epikut Plus
• Version Model Number: ILHE 5011N
• Catalog Number: ILHE 5011N
• Company DUNS: 904569092
• Company Name: Sin Sistema de Implante Nacional S/A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899995273581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211921

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-25
• Device Publish Date: 2022-01-17

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