Aspirating Biopsy Needle MBR-000012

GUDID B634MBR0000121

Aspirating Biopsy Needle

AURIS HEALTH, INC.

Flexible endoscopic biopsy handpiece/needle

• Primary Device ID: B634MBR0000121
• NIH Device Record Key: c80e8278-ae09-407e-926c-b50f2ad3f281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspirating Biopsy Needle
• Version Model Number: MBR-000012
• Catalog Number: MBR-000012
• 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	B634MBR0000120 [Primary]
HIBCC	B634MBR0000121 [Package]; Contains: B634MBR0000120; 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-08

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