Gangi-SoftGuard Coaxial Needle SG13-071

GUDID 17350031350347

Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 7.1 cm.

Apriomed AB

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• Primary Device ID: 17350031350347
• NIH Device Record Key: 2628150e-07ae-42ef-967b-512fd96a674a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gangi-SoftGuard Coaxial Needle
• Version Model Number: G034
• Catalog Number: SG13-071
• Company DUNS: 631734758
• Company Name: Apriomed AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com
• Phone: +46184301440
• Email: info@apriomed.com

Device Dimensions

• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge
• Length: 7.1 Centimeter
• Needle Gauge: 13 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350031350340 [Primary]
GS1	17350031350347 [Package]; Contains: 07350031350340; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	27350031350344 [Package]; Package: Transportation box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181756

FDA Product Code

• FCG: Biopsy Needle

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: 2023-05-02
• Device Publish Date: 2023-04-24

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• 27350031351266: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 27350031351259: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
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• 27350031351228: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
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• 17350031350408: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350392: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350385: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350378: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350361: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350354: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350347: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa
• 17350031350330: Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loa