Curved Tip Needle

GUDID 14526737170388

25G x 3 1/2"(89mm) Clear plastic hub

HAKKO CO.,LTD.

Peripheral nerve-block blunt needle

• Primary Device ID: 14526737170388
• NIH Device Record Key: 48f92880-fa04-4367-bc1c-6d7c6eb8149d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Tip Needle
• Version Model Number: SBB89-25
• 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: 25 Gauge
• Length: 89 Millimeter
• Needle Gauge: 25 Gauge
• Length: 89 Millimeter
• Needle Gauge: 25 Gauge
• Length: 89 Millimeter
• Needle Gauge: 25 Gauge
• Length: 89 Millimeter
• Needle Gauge: 25 Gauge
• Length: 89 Millimeter
• Needle Gauge: 25 Gauge
• Length: 89 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737170381 [Primary]
GS1	14526737170388 [Package]; Contains: 04526737170381; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961151

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

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 [Curved Tip Needle]

• 14526737170388: 25G x 3 1/2"(89mm) Clear plastic hub
• 14526737170371: 25G x 2 1/2"(63mm) Clear plastic hub
• 14526737170364: 22G x 6"(152mm) Clear plastic hub
• 14526737170357: 22G x 7"(178mm) Clear plastic hub
• 14526737170340: 22G x 5"(127mm) Clear plastic hub
• 14526737170333: 22G x 3 1/2"(89mm) Clear plastic hub