Suresafe 1ml Syringe FD-SSFX01-25

GUDID 05391530750295

Suresafe 1ml syringe - 25G x 5/8" Automatic retractable syringe - Sterile

DMC MEDICAL LIMITED

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 05391530750295
• NIH Device Record Key: e0247886-7a30-4e18-8b2c-075a691af550
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suresafe 1ml Syringe
• Version Model Number: 1ml Syringe - 25G x 5/8"
• Catalog Number: FD-SSFX01-25
• Company DUNS: 989772017
• Company Name: DMC MEDICAL LIMITED
• Device Count: 1
• 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	05391530750271 [Primary]
GS1	05391530750288 [Package]; Contains: 05391530750271; Package: [100 Units]; In Commercial Distribution
GS1	05391530750295 [Package]; Contains: 05391530750288; Package: [21 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141349

FDA Product Code

• MEG: Syringe, Antistick

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: 2016-08-11

On-Brand Devices [Suresafe 1ml Syringe]

• 05391530750325: Suresafe 1ml Syringe - Automatic Retraction - 25G x 1" Sterile Syringe
• 05391530750295: Suresafe 1ml syringe - 25G x 5/8" Automatic retractable syringe - Sterile