PORT LOCATOR MFPL-001

GUDID 07445161009487

PORT LOCATOR Motiva Flora Port Locator

Establishment Labs S.A.

Tissue expander injection port locator

• Primary Device ID: 07445161009487
• NIH Device Record Key: 3ecf8ec3-d4ee-45be-8634-7fdfc38a7863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORT LOCATOR
• Version Model Number: MFPL-001
• Catalog Number: MFPL-001
• Company DUNS: 853166098
• Company Name: Establishment Labs 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: false
• Lot Batch: false
• 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	07445161009487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211676

FDA Product Code

• LCJ: Tissue Expander And Accessories

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: 2023-12-18
• Device Publish Date: 2023-12-08

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