Compass Steerable Needle

GUDID 00860009430211

The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions.

SERPEX MEDICAL INC.

Body aspiration needle, single-use

• Primary Device ID: 00860009430211
• NIH Device Record Key: 4d8d778a-582a-4dfb-ba4d-2a7e726e8ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compass Steerable Needle
• Version Model Number: CSN1001
• Company DUNS: 118905661
• Company Name: SERPEX 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009430211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252874

FDA Product Code

• KTI: Bronchoscope Accessory

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: 2025-12-16
• Device Publish Date: 2025-12-08

On-Brand Devices [Compass Steerable Needle]

• 00860009430228: Transbronchial Biopsy Needle
• 00860009430211: The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a