Securegard 5448E

GUDID 05999039514471

Securegard 3ml 23Gx1" syringe in tray

SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag

Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle

• Primary Device ID: 05999039514471
• NIH Device Record Key: b489524a-ead0-45ca-82a7-49b9e1679639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Securegard
• Version Model Number: 1.0
• Catalog Number: 5448E
• Company DUNS: 401217526
• Company Name: SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag
• 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: 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	05999039514457 [Unit of Use]
GS1	05999039514464 [Primary]
GS1	05999039514471 [Package]; Contains: 05999039514464; Package: carton [28 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993609

FDA Product Code

• MEG: Syringe, Antistick

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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Securegard]

• 5999039513757: Securegard 3 ml 21Gx 1 1/4" syringe
• 5999039512477: Securegard 5 ml 21Gx1" syringe
• 5999039512439: Securegard 5 ml 22Gx1" syringe
• 5999039512392: Securegard 3 ml 21Gx1" syringe
• 5999039512354: Securegard 3 ml 22Gx1 1/2" syringe
• 5999039512316: Securegard 3 ml 22Gx1" syringe
• 5999039512231: Securegard 3 ml 25Gx1" syringe
• 5999039512156: Securegard 1ml 30Gx1/2" insulin syringe
• 5999039512118: Securegard 1 ml 25Gx1" syringe
• 5999039510633: Securegard 5 ml 21Gx1 1/4" syringe
• 5999039501914: Securegard 5 ml 22Gx1 1/4" syringe
• 5999039501884: Securegard 5 ml 23Gx1 1/4" syringe
• 5999039501853: Securegard 5 ml 23Gx1" syringe
• 5999039501495: Securegard 3 ml 21Gx1 1/2" syringe
• 5999039501464: Securegard 3 ml 22Gx1 1/4" syringe
• 5999039501433: Securegard 3 ml 23Gx1 1/4" syringe
• 5999039501402: Securegard 3 ml 23Gx1" syringe
• 5999039501372: Securegard 3 ml 25Gx5/8" syringe
• 5999039500177: Securegard 1 ml 25Gx5/8" syringe
• 5999039500115: Securegard 1 ml 27Gx1/2" syringe
• 5999039500085: Securegard 1 ml 27Gx1/2" insulin syringe
• 5999039500023: Securegard 1 ml 29Gx1/2" insulin syringe
• 05999039511999: Securegard 1ml 25Gx1" syringe in tray
• 05999039514471: Securegard 3ml 23Gx1" syringe in tray