DropSafe Syringe with Safety Needle 6073

GUDID 05903999600327

Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.

HTL STREFA S A

General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle

• Primary Device ID: 05903999600327
• NIH Device Record Key: f7c7fc9d-f279-4c90-9c70-0a4e7f511f47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DropSafe Syringe with Safety Needle
• Version Model Number: 1mL 25Gx1”
• Catalog Number: 6073
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com
• Phone: +484227000010
• Email: info@htl-strefa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903999600327 [Primary]
GS1	15903999600324 [Package]; Package: Shelf box [50 Units]; In Commercial Distribution
GS1	25903999600321 [Package]; Contains: 15903999600324; Package: Shipper box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101359

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: 2021-09-14
• Device Publish Date: 2021-09-06

On-Brand Devices [DropSafe Syringe with Safety Needle]

• 25907996099225: The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration and inj
• 25907996099218: The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration and inj
• 25907996099201: The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration and inj
• 05903999600327: Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is us
• 05903999600310: Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is us