Allergy Tray

GUDID 00616784693637

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784693637
• NIH Device Record Key: 34fbd204-5ec8-46dc-a6e8-00dfdafc9764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allergy Tray
• Version Model Number: 6936
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 25
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784693606 [Unit of Use]
GS1	00616784693613 [Primary]
GS1	00616784693637 [Package]; Contains: 00616784693613; Package: Master Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113091

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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-09-08

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• 00810180842013 - ColorFit Adhesive Fabric Bandages, Dark Brown, 1" x 3": 2025-06-10 Sterile-EO
• 00810180842020 - ColorFit Adhesive Fabric Bandages, Brown, 1" x 3": 2025-06-10 Sterile-EO