TechLITE® Lancets, 26g

GUDID 10015482880160

TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling.

ARKRAY USA, INC.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 10015482880160
• NIH Device Record Key: 1f1c8edd-2a95-427d-b2ef-f8797d60801f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechLITE® Lancets, 26g
• Version Model Number: 880126
• 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: false
• 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

• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482880163 [Primary]
GS1	10015482880160 [Package]; Contains: 00015482880163; Package: Case Pack [24 Units]; In Commercial Distribution
GS1	20015482880167 [Package]; Package: Master Shipper [12 Units]; In Commercial Distribution
GS1	50015482880168 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220475

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2023-10-05
• Device Publish Date: 2023-09-27

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