SHOPKO Unifine Pentips Plus - 5mmx31G pen needles AN 3850SKO

GUDID 00761059852551

For use with injectors for the subcutaneous injection of approved drugs, including insulin

Shopko

Autoinjector needle Autoinjector needle

• Primary Device ID: 00761059852551
• NIH Device Record Key: 974c3348-58d7-4a13-a7db-d11cee376ea2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHOPKO Unifine Pentips Plus - 5mmx31G pen needles
• Version Model Number: AN 3850SKO
• Catalog Number: AN 3850SKO
• Company DUNS: 023252638
• Company Name: Shopko
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 920-429-2211
• Email: xx@xx.xx
• Phone: 920-429-2211
• Email: xx@xx.xx

Device Dimensions

• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00761059850004 [Unit of Use]
GS1	00761059850557 [Primary]
GS1	00761059851554 [Package]; Contains: 00761059850557; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00761059852551 [Package]; Contains: 00761059851554; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by Shopko

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• 10400265047203 - Shopko Tampons: 2019-12-09
• 10400265047388 - Shopko Tampons: 2019-12-09
• 10400265047463 - Shopko Tampons: 2019-12-09
• 10400265047531 - Shopko Tampons: 2019-12-09
• 00761059821557 - SHOPKO Unifine Pentips Plus - 12mmx29G pen needles: 2018-07-06 For use with injectors for the subcutaneous injection of approved drugs, including insulin