BIOSUC-C7

GUDID 04526737120027

22G x 50mm with suction syringe

HAKKO CO.,LTD.

Body aspiration needle, single-use

• Primary Device ID: 04526737120027
• NIH Device Record Key: 0c53a280-d841-4fe6-aaad-252744b44c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSUC-C7
• Version Model Number: BIO2250
• 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: 22 Gauge
• Length: 50 Millimeter
• Needle Gauge: 22 Gauge
• Length: 50 Millimeter
• Needle Gauge: 22 Gauge
• Length: 50 Millimeter
• Needle Gauge: 22 Gauge
• Length: 50 Millimeter
• Needle Gauge: 22 Gauge
• Length: 50 Millimeter
• Needle Gauge: 22 Gauge
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737120027 [Primary]
GS1	14526737120024 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013108

FDA Product Code

• KNW: Instrument, Biopsy

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 [BIOSUC-C7]

• 04526737120034: 22G x 100mm with suction syringe
• 04526737120027: 22G x 50mm with suction syringe
• 14526737120017: 20G x 100mm with suction syringe
• 04526737120003: 20G x 50mm with suction syringe