Entellus Medical Reinforced Anesthesia Needle RAN-027-2

GUDID 00857326005550

The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnasally administer anesthetic solutions. The needle may be reshaped along the 3.5” length.

ENTELLUS MEDICAL, INC.

Hypodermic needle, single-use

• Primary Device ID: 00857326005550
• NIH Device Record Key: 34194f4d-a749-4a72-8b92-2d0a28407209
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entellus Medical Reinforced Anesthesia Needle
• Version Model Number: RAN
• Catalog Number: RAN-027-2
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 2
• 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: 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	00857326005550 [Primary]
GS1	10857326005557 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163435

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-05-18

On-Brand Devices [Entellus Medical Reinforced Anesthesia Needle ]

• 00857326005574: The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnas
• 00857326005550: The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnas