Bonopty Penetration Set 10-1072

GUDID 17350031350255

Manually operated, sterile, single use coaxial bone biopsy system.

Apriomed AB

Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle Bone biopsy needle

• Primary Device ID: 17350031350255
• NIH Device Record Key: f5d93bc7-f671-490a-9317-351a509eeeb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonopty Penetration Set
• Version Model Number: G025
• Catalog Number: 10-1072
• Company DUNS: 631734758
• Company Name: Apriomed AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter
• Needle Gauge: 14 Gauge
• Length: 9.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350031350258 [Primary]
GS1	17350031350255 [Package]; Contains: 07350031350258; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	27350031350252 [Package]; Package: Transportation bix [12 Units]; In Commercial Distribution

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

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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• 17350031350255: Manually operated, sterile, single use coaxial bone biopsy system.
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