DOMREX™ Safety needle

GUDID 10628032025104

Domrex Pharma Inc

Hypodermic needle, single-use

• Primary Device ID: 10628032025104
• NIH Device Record Key: 323a2e55-f821-4604-9969-3fc6298bd66d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Safety needle
• Version Model Number: 25Gx1''
• Company DUNS: 242411127
• Company Name: Domrex Pharma 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	00628032025107 [Primary]
GS1	10628032025104 [Package]; Contains: 00628032025107; Package: Case [16 Units]; In Commercial Distribution
GS1	90628032025100 [Unit of Use]

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: 2024-01-29
• Device Publish Date: 2024-01-21

Devices Manufactured by Domrex Pharma Inc

• 00628032900015 - DOMREX™ Powder-Free Nitrile Exam Gloves: 2024-01-30
• 10628032000019 - DOMREX™ Syringe: 2024-01-29
• 10628032000033 - DOMREX™ Syringe: 2024-01-29
• 10628032000057 - DOMREX™ Syringe: 2024-01-29
• 10628032000101 - DOMREX™ Syringe: 2024-01-29
• 10628032025104 - DOMREX™ Safety needle: 2024-01-29
• 10628032025104 - DOMREX™ Safety needle: 2024-01-29
• 10628032125101 - DOMREX™ Syringe with safety needle: 2024-01-29
• 10628032222558 - DOMREX™ PI GLOVES: 2024-01-29