SureAim Coaxial Biopsy Needle

GUDID 06954414642292

Coaxial Biopsy Needle

Canyon Medical Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 06954414642292
• NIH Device Record Key: 47da6a34-4484-41e1-8ec7-3a48407b94c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureAim Coaxial Biopsy Needle
• Version Model Number: CN-17/119-1
• 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	06954414642292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222865

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: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [SureAim Coaxial Biopsy Needle]

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• 06954414659627: Coaxial Biopsy Needle
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• 06954414659580: Coaxial Biopsy Needle
• 06954414659573: Coaxial Biopsy Needle
• 06954414659566: Coaxial Biopsy Needle
• 06954414646153: Coaxial Biopsy Needle
• 06954414646146: Coaxial Biopsy Needle
• 06954414646139: Coaxial Biopsy Needle
• 06954414646122: Coaxial Biopsy Needle
• 06954414646115: Coaxial Biopsy Needle
• 06954414646108: Coaxial Biopsy Needle
• 06954414642209: Coaxial Biopsy Needle
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• 06954414660050: Coaxial Biopsy Needle
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• 06954414660036: Coaxial Biopsy Needle
• 06954414660029: Coaxial Biopsy Needle
• 06954414660012: Coaxial Biopsy Needle
• 06954414660005: Coaxial Biopsy Needle
• 06954414659993: Coaxial Biopsy Needle
• 06954414659986: Coaxial Biopsy Needle
• 06954414659979: Coaxial Biopsy Needle
• 06954414659962: Coaxial Biopsy Needle
• 06954414659955: Coaxial Biopsy Needle
• 06954414659948: Coaxial Biopsy Needle
• 06954414659931: Coaxial Biopsy Needle
• 06954414659924: Coaxial Biopsy Needle
• 06954414659917: Coaxial Biopsy Needle
• 06954414659900: Coaxial Biopsy Needle
• 06954414659894: Coaxial Biopsy Needle
• 06954414659887: Coaxial Biopsy Needle
• 06954414659870: Coaxial Biopsy Needle
• 06954414659863: Coaxial Biopsy Needle
• 06954414659856: Coaxial Biopsy Needle
• 06954414659849: Coaxial Biopsy Needle
• 06954414659832: Coaxial Biopsy Needle
• 06954414659825: Coaxial Biopsy Needle