DropSafe® Insulin Safety Syringe with Fixed Needle 6081

GUDID 05903999600778

DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin.

HTL STREFA S A

Insulin syringe/needle, safety

• Primary Device ID: 05903999600778
• NIH Device Record Key: f27e048f-9d44-4261-85f3-92ae99e3c5b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DropSafe® Insulin Safety Syringe with Fixed Needle
• Version Model Number: 0.5ml 31G x 6mm
• Catalog Number: 6081
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903999600778 [Package]; Contains: 85903999600774; Package: shelf box [100 Units]; In Commercial Distribution
GS1	25903999600772 [Package]; Package: shipper box [8 Units]; In Commercial Distribution
GS1	85903999600774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132681

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: 2021-12-22
• Device Publish Date: 2021-12-10

On-Brand Devices [DropSafe® Insulin Safety Syringe with Fixed Needle]

• 05903999600792: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600785: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600778: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600730: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600723: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600716: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600709: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 05903999600693: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet
• 85903999600682: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safet