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.

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• 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

Devices Manufactured by ARKRAY USA, INC.

• 50015482234237 - TechLITE PLUS PEN NEEDLES: 2024-03-19Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin.
• 50015482234237 - TechLITE PLUS PEN NEEDLES: 2024-03-19 Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin.
• 10015482880160 - TechLITE® Lancets, 26g: 2023-10-05 TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling.
• 00015482880187 - TechLITE® Lancets, 28g: 2023-09-27 TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling.
• 10015482232297 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482234321 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482235311 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482236325 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482238312 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.