DropSafe® Insulin Safety Syringe with Fixed Needle

Basic Information

• Brand Name: DropSafe® Insulin Safety Syringe with Fixed Needle
• Primary DI: 85903999600682
• Version / Model: 0.3ml 29G x 12.5mm
• Catalog Number: 6075
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-10
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: f7ea0c03-6e7f-4b8b-8736-f7eb1d11ee2d

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34973	Insulin syringe/needle, safety	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	85903999600682	GS1
Package	05903999600686	GS1	shelf box	100	In Commercial Distribution
Package	25903999600680	GS1	shipper box	8	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132681	000