DOMREX™ Syringe with safety needle

GUDID 10628032325105

Domrex Pharma Inc

General-purpose syringe/needle

• Primary Device ID: 10628032325105
• NIH Device Record Key: b81cb8c3-f50f-4d6c-8f6a-d05933a6ba8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Syringe with safety needle
• Version Model Number: 3ML
• 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	00628032325108 [Primary]
GS1	10628032325105 [Package]; Contains: 00628032325108; Package: [8 Units]; In Commercial Distribution
GS1	90628032325101 [Unit of Use]

FDA Product Code

• FMF: Syringe, Piston

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

On-Brand Devices [DOMREX™ Syringe with safety needle]

• 10628032500182: 3ML 25GX5/8"
• 10628032500175: 3ML 22GX1"
• 10628032500151: 3ML 21G x 1''
• 10628032325105: 3ML
• 10628032125101: 1ML