SureCore Automatic Disposable Biopsy Needle

GUDID 06954414667400

Automatic Disposable Biopsy Needle

Canyon Medical Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 06954414667400
• NIH Device Record Key: f78eb483-4cbc-4940-90c0-ebe8d7cd392c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCore Automatic Disposable Biopsy Needle
• Version Model Number: BN-1/162022-1
• Company DUNS: 527310648
• Company Name: Canyon 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06954414667400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233031

FDA Product Code

• KNW: Instrument, Biopsy

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: 2024-02-08
• Device Publish Date: 2024-01-31

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