EchoTuohy Epidural Needle

GUDID 14526737171071

18G x 3 1/2"(89mm) Plastic hub, with wings Calibrations & Echogenic Tip.

HAKKO CO.,LTD.

Epidural needle, non-threaded

• Primary Device ID: 14526737171071
• NIH Device Record Key: e1e22a50-0034-48de-a5ac-eef446a65c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoTuohy Epidural Needle
• Version Model Number: E3-2150-18
• 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: 18 Gauge
• Length: 89 Millimeter
• Needle Gauge: 18 Gauge
• Length: 89 Millimeter
• Needle Gauge: 18 Gauge
• Length: 89 Millimeter
• Needle Gauge: 18 Gauge
• Length: 89 Millimeter
• Needle Gauge: 18 Gauge
• Length: 89 Millimeter
• Needle Gauge: 18 Gauge
• Length: 89 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737171074 [Primary]
GS1	14526737171071 [Package]; Contains: 04526737171074; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961152

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 [EchoTuohy Epidural Needle]

• 14526737171101: 18G x 6"(152mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171095: 17G x 6"(152mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171088: 18G x 5"(127mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171071: 18G x 3 1/2"(89mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171064: 17G x 5"(127mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171057: 17G x 3 1/2"(89mm) Plastic hub, with wings Calibrations & Echogenic Tip.
• 14526737171040: 20G x 3 1/2"(89mm) Plastic hub, with wings Calibrations & Echogenic Tip.