Compass Steerable Needle

GUDID 00860009430228

Transbronchial Biopsy Needle

SERPEX MEDICAL INC.

Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle Flexible endoscopic biopsy handpiece/needle

• Primary Device ID: 00860009430228
• NIH Device Record Key: f0041a36-6c25-461c-bd1e-3863321bab34
• 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

Customer Support Contacts

• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com
• Phone: 18009838698
• Email: info@serpexmedical.com

Device Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009430228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221206

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: 2023-03-27
• Device Publish Date: 2023-03-17