PTC Spinal Needle

GUDID 14526737120413

18G x 2"(51mm) Plastic hub, depth guide Rough surface, calibrations

HAKKO CO.,LTD.

Peripheral nerve-block sharp needle

• Primary Device ID: 14526737120413
• NIH Device Record Key: eaab9afd-0626-448b-a8fc-c4105a0e10d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTC Spinal Needle
• Version Model Number: 2PTC18
• 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

• Length: 51 Millimeter
• Needle Gauge: 18 Gauge
• Length: 51 Millimeter
• Needle Gauge: 18 Gauge
• Length: 51 Millimeter
• Needle Gauge: 18 Gauge
• Length: 51 Millimeter
• Needle Gauge: 18 Gauge
• Length: 51 Millimeter
• Needle Gauge: 18 Gauge
• Length: 51 Millimeter
• Needle Gauge: 18 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737120416 [Primary]
GS1	14526737120413 [Package]; Contains: 04526737120416; 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: 2017-05-20

On-Brand Devices [PTC Spinal Needle]

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• 04526737120393: 18G x 4"(102mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120386: 18G x 3"(76mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120379: 25G x 4"(102mm) Plastic hub, depth guide With 1cm calibrations
• 04526737120218: 22G x 2"(51mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120201: 20G x 3"(76mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120195: 20G x 2"(51mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120188: 25G x 5"(127mm) Plastic hub, depth guide With 1cm calibrations
• 04526737120171: 22G x 7"(178mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120164: 22G x 5"(127mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120157: 20G x 4"(102mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120140: 22G x 4"(102mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120133: 20G x 5"(127mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120126: 25G x 6"(152mm) Plastic hub, depth guide With 1cm calibrations
• 04526737120119: 22G x 8"(203mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120102: 22G x 6"(152mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120096: 20G x 8"(203mm) Plastic hub, depth guide Rough surface, calibrations
• 14526737120086: 20G x 6"(152mm) Plastic hub, depth guide Rough surface, calibrations
• 04526737120072: 18G x 8"(203mm) Plastic hub, depth guide Rough surface, calibrations
• 14526737120062: 18G x 6"(152mm) Plastic hub, depth guide Rough surface, calibrations