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

Devices Manufactured by DYNAREX CORPORATION

• 00810180843331 - Durma+ DynaRule Disposable Paper Rulers: 2026-04-01
• 00810180845106 - Cotton Tipped Wood Applicators, Sterile: 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 1 per pouch
• 00810180845113 - Cotton Tipped Wood Applicators, Sterile: 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 2 per Pouch
• 00810180840712 - CurPro Dermal Curettes,2 mm: 2026-03-27 Sterile-R
• 00840117347892 - Medi-Cut Safety Scalpel: 2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15
• 00810180844901 - Disposable Prep Razors: 2026-03-25 Disposable Prep Razors
• 00810180844918 - Medicine Cups 1oz: 2026-03-25
• 00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal: 2026-03-25 Sterile-EO