TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)

GUDID 10015482263123

TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.

ARKRAY USA, INC.

Insulin syringe/needle, basic

• Primary Device ID: 10015482263123
• NIH Device Record Key: b8286db9-c92b-43b8-a585-fc324e29aa5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)
• Version Model Number: 260312
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 10
• 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: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx

Device Dimensions

• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482263126 [Package]; Contains: 00015482613129; Package: Carton [10 Units]; In Commercial Distribution
GS1	00015482613129 [Primary]
GS1	10015482263123 [Package]; Contains: 00015482263126; Package: Master Shipper [10 Units]; In Commercial Distribution
GS1	50015482613124 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153537

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-28
• Device Publish Date: 2018-01-09

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