TechLITE PLUS PEN NEEDLES

GUDID 50015482234237

Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin.

ARKRAY USA, INC.

Autoinjector needle

• Primary Device ID: 50015482234237
• NIH Device Record Key: b19cc6ed-3be3-4aac-a8f3-1e9873312405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechLITE PLUS PEN NEEDLES
• Version Model Number: 234232
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx

Device Dimensions

• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482234232 [Primary]
GS1	50015482234237 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161950

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2024-03-19
• Device Publish Date: 2024-03-11

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• 00015482117313 - AUTION MAX™ AX-4060 Analyzer: 2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend
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