EchoStim EB

GUDID 04526737171142

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

HAKKO CO.,LTD.

Peripheral anaesthesia single-administration set, non-medicated

• Primary Device ID: 04526737171142
• NIH Device Record Key: 395d315c-076b-4c17-87d3-5c0f9201c9c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoStim EB
• 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: 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: 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

Device Dimensions

• Needle Gauge: 21 Gauge
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737170664 [Previous]
GS1	04526737171142 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-10
• Device Publish Date: 2022-10-01

On-Brand Devices [EchoStim EB]

• 04526737171166: 21G x 6"(150mm) Facet tip, 30 degree bevel with fixed tubing non-insulated
• 14526737171156: 21G x 4"(100mm) Facet tip, 30 degree bevel with fixed tubing non-insulated
• 04526737171142: 21G x 3 1/8"(80mm) Facet tip, 30 degree bevel with fixed tubing non-insulated
• 14526737171132: 21G x 2"(50mm) Facet tip, 30 degree bevel with fixed tubing non-insulated