NovoTwist® 32G 185389

GUDID 30301691853892

NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.

NOVO NORDISK INC.

Autoinjector needle

• Primary Device ID: 30301691853892
• NIH Device Record Key: 83ddd180-00ba-4118-b586-1a8fe45909bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoTwist® 32G
• Version Model Number: 185389
• Catalog Number: 185389
• Company DUNS: 012177531
• Company Name: NOVO NORDISK 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: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com

Device Dimensions

• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301691853891 [Primary]
GS1	05712249050054 [Unit of Use]
GS1	30301691853892 [Package]; Contains: 00301691853891; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093109

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: 2016-09-17

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