Sonopsy-C1

GUDID 14526737120055

1 21G x 100mm biopsy needle with suction syringe 3 Filter paper

HAKKO CO.,LTD.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 14526737120055
• NIH Device Record Key: ddebb5e1-ad1e-4c90-87bc-4efca1daab09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonopsy-C1
• Version Model Number: SON21100
• Company DUNS: 693273427
• Company Name: HAKKO CO.,LTD.
• 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: false
• 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: 513-271-2117
• Email: SAst@havels.com
• Phone: 513-271-2117
• Email: SAst@havels.com
• Phone: 513-271-2117
• Email: SAst@havels.com
• Phone: 513-271-2117
• Email: SAst@havels.com
• Phone: 513-271-2117
• Email: SAst@havels.com
• Phone: 513-271-2117
• Email: SAst@havels.com

Device Dimensions

• Needle Gauge: 21 Gauge
• Length: 100 Millimeter
• Needle Gauge: 21 Gauge
• Length: 100 Millimeter
• Needle Gauge: 21 Gauge
• Length: 100 Millimeter
• Needle Gauge: 21 Gauge
• Length: 100 Millimeter
• Needle Gauge: 21 Gauge
• Length: 100 Millimeter
• Needle Gauge: 21 Gauge
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737120058 [Primary]
GS1	14526737120055 [Package]; Contains: 04526737120058; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013109

FDA Product Code

• FCG: Biopsy Needle Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Sonopsy-C1]

• 14526737120055: 1 21G x 100mm biopsy needle with suction syringe 3 Filter paper
• 14526737120048: 1 21G x 50mm biopsy needle with suction syringe 3 Filter paper