FleXNeedle 10005-1

GUDID 00856571007012

Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.

BRONCUS MEDICAL INC.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 00856571007012
• NIH Device Record Key: 2e8c1d55-d348-4ba5-9b08-51378eb3cd87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FleXNeedle
• Version Model Number: 10005-1
• Catalog Number: 10005-1
• Company DUNS: 078684808
• Company Name: BRONCUS MEDICAL 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

Customer Support Contacts

• Phone: 650-428-1600
• Email: CustomerSupport@Broncus.com

Device Dimensions

• Needle Gauge: 18 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090853

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-22
• Device Publish Date: 2017-05-12

Devices Manufactured by BRONCUS MEDICAL INC.

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• 00856571007920 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007937 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007944 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007951 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007968 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007975 - BroncTru™ Transbronchial Access Tool: 2025-04-08
• 00856571007982 - BroncTru™ Transbronchial Access Tool: 2025-04-08