LiNA OperåScope™ Needle 4mm

GUDID 05708265012305

LiNA OperåScope™ Needle 4mm, minimum channel diameter: Ø 2mm

Lina Medical ApS

General-purpose endoscopic needle, single-use

• Primary Device ID: 05708265012305
• NIH Device Record Key: 2b175dae-901e-4046-96d6-1118950a10e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiNA OperåScope™ Needle 4mm
• Version Model Number: OP-NEE4-6
• Company DUNS: 305088619
• Company Name: Lina Medical ApS
• 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

Customer Support Contacts

• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com
• Phone: +48612222149
• Email: info.poland@lina-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708265012299 [Primary]
GS1	05708265012305 [Package]; Contains: 05708265012299; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

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: 2022-10-11
• Device Publish Date: 2022-10-03

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• 05708265013975 - LiNA CystoVu™ HD: 2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope , Reverse Deflection
• 05708265014002 - LiNA ScopeVu™: 2024-10-01 LiNA ScopeVu™ Full HD display and light source
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