EchoBlock

GUDID 14526737170661

21G x 3 1/8"(80mm) Facet tip, 30 degree bevel with fixed tubing

HAKKO CO.,LTD.

Peripheral nerve-block blunt needle

• Primary Device ID: 14526737170661
• NIH Device Record Key: e3858f15-bee0-41f3-9c20-50ba23b774ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoBlock
• Version Model Number: EB-2180
• 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: 80 Millimeter
• Needle Gauge: 21 Gauge
• Length: 80 Millimeter
• Needle Gauge: 21 Gauge
• Length: 80 Millimeter
• Needle Gauge: 21 Gauge
• Length: 80 Millimeter
• Needle Gauge: 21 Gauge
• Length: 80 Millimeter
• Needle Gauge: 21 Gauge
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737170664 [Primary]
GS1	14526737170661 [Package]; Contains: 04526737170664; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063380

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 [EchoBlock]

• 14526737170685: 21G x 6"(150mm) Facet tip, 30 degree bevel with fixed tubing
• 14526737170678: 21G x 4"(100mm) Facet tip, 30 degree bevel with fixed tubing
• 14526737170661: 21G x 3 1/8"(80mm) Facet tip, 30 degree bevel with fixed tubing
• 14526737170654: 21G x 2"(50mm) Facet tip, 30 degree bevel with fixed tubing