SunMark

GUDID 20357515892618

ULTIMED, INC.

Autoinjector needle Autoinjector needle

• Primary Device ID: 20357515892618
• NIH Device Record Key: 7443b2a9-e3be-4aad-8b23-8e93aa9373f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunMark
• Version Model Number: 2789261
• Company DUNS: 024723541
• Company Name: ULTIMED, INC.
• Device Count: 50
• 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	00357515710055 [Unit of Use]
GS1	20357515892618 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SunMark]

• 20357515892618: 2789261
• 20357515885603: 2788560