Navigation Patient Patches MBR-000016

GUDID B634MBR0000161

Navigation Patient Patches (Quantity of 60)

AURIS HEALTH, INC.

Hypoallergenic skin adhesive tape

• Primary Device ID: B634MBR0000161
• NIH Device Record Key: f2ee1f2a-f1b5-4c65-b07d-f45ff01f4cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Patient Patches
• Version Model Number: MBR-000016
• Catalog Number: MBR-000016
• Company DUNS: 015823456
• Company Name: AURIS HEALTH, INC.
• 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: 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
HIBCC	B634MBR0000160 [Primary]
HIBCC	B634MBR0000161 [Package]; Contains: B634MBR0000160; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173760

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-06-08

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