Coborn's/UltiGuard

GUDID 30357515035531

5mm Coborn's UltiGuard Safe Pack Pen Needles

ULTIMED, INC.

Autoinjector needle

• Primary Device ID: 30357515035531
• NIH Device Record Key: 7613ebd3-e03c-4a71-85f8-6ec642ce5e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coborn's/UltiGuard
• Version Model Number: 09553CB
• Company DUNS: 024723541
• Company Name: ULTIMED, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515710130 [Unit of Use]
GS1	20357515035534 [Primary]
GS1	30357515035531 [Package]; Contains: 20357515035534; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100812

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2019-10-28
• Device Publish Date: 2019-10-18