3ml Suresafe Syringe FD-SSIC03-21-01

GUDID 05391530750561

3ml Suresafe Automatic Retractable Syringe - 21G x 1 1/2" - Sterile

DMC MEDICAL LIMITED

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 05391530750561
• NIH Device Record Key: 44edb2e6-e278-4a41-99a6-27abe0b81e2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3ml Suresafe Syringe
• Version Model Number: 3ml Syringe - 21G x 1 1/2"
• Catalog Number: FD-SSIC03-21-01
• 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	05391530750547 [Primary]
GS1	05391530750554 [Package]; Contains: 05391530750547; Package: [100 Units]; In Commercial Distribution
GS1	05391530750561 [Package]; Contains: 05391530750554; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143497

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: 2016-08-12

On-Brand Devices [3ml Suresafe Syringe]

• 05391530750561: 3ml Suresafe Automatic Retractable Syringe - 21G x 1 1/2" - Sterile
• 05391530750530: 3ml Suresafe Automatic Retractable 22G x 1" Syringe - Sterile
• 05391530750509: 3ml Suresafe Automatic Retractable 21G x 1" Syringe - Sterile
• 05391530750479: 3ml Suresafe Automatic Retractable Syringe 22G x 1 1/2" - Sterile
• 05391530750448: 3ml Suresafe Automatic Retractable Syringe - 23G x 1 1/2" - Sterile
• 05391530750417: 3ml Suresafe Automatic Retractable Syringe - 23G x 1" - Sterile
• 05391530750387: 3ml Suresafe Syringe Automatic Retractable Syringe 25G x 1" - Sterile
• 05391530750356: 3ml Suresafe Automatic Retractable Syringe - 25G x 5/8" Sterile