TechLITE PEN NEEDLES

GUDID 10015482235311

Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.

ARKRAY USA, INC.

Autoinjector needle

• Primary Device ID: 10015482235311
• NIH Device Record Key: c852019b-68a3-42cb-8f0b-54694354495a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechLITE PEN NEEDLES
• Version Model Number: 235131
• 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
• 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: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482235314 [Primary]
GS1	10015482235311 [Package]; Contains: 00015482235314; Package: Case Pack [24 Units]; In Commercial Distribution
GS1	50015482235319 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171982

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-08
• Device Publish Date: 2019-05-14

On-Brand Devices [TechLITE PEN NEEDLES]

• 10015482238312: Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneou
• 10015482236325: Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneou
• 10015482235311: Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneou
• 10015482234321: Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneou
• 10015482232297: Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneou