Renú Transoral Needle 12-000-00-ND1

GUDID 00856509002669

Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use.

CYTOPHIL, INC.

General-purpose endoscopic needle, single-use

• Primary Device ID: 00856509002669
• NIH Device Record Key: 9c1a5c43-9cb1-41c0-a7ff-73fa892f3417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renú Transoral Needle
• Version Model Number: 12-000-00-ND1
• Catalog Number: 12-000-00-ND1
• Company DUNS: 024222105
• Company Name: CYTOPHIL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00856509002669 [Primary]

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

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: 2019-11-07
• Device Publish Date: 2019-10-30

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