PTC Spinal Needle

GUDID 04526737120393

18G x 4"(102mm) Plastic hub, depth guide Rough surface, calibrations

HAKKO CO.,LTD.

Peripheral nerve-block sharp needle

• Primary Device ID: 04526737120393
• NIH Device Record Key: 2e2cc212-f0a9-4b4f-8bea-de094e09f031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTC Spinal Needle
• Version Model Number: 4PTC18
• 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: 102 Millimeter
• Needle Gauge: 18 Gauge
• Length: 102 Millimeter
• Needle Gauge: 18 Gauge
• Length: 102 Millimeter
• Needle Gauge: 18 Gauge
• Length: 102 Millimeter
• Needle Gauge: 18 Gauge
• Length: 102 Millimeter
• Needle Gauge: 18 Gauge
• Length: 102 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04526737120393 [Primary]
GS1	14526737120390 [Package]; 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

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• 04526737120393: 18G x 4"(102mm) Plastic hub, depth guide Rough surface, calibrations
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