DropSafe Safety Needle LD

Basic Information

• Brand Name: DropSafe Safety Needle LD
• Primary DI: 05907996099962
• Version / Model: 23G x 1"
• Catalog Number: 6069
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-06
• Public Version: 1
• Public Version Date: 2021-09-14
• Public Version Status: New
• Public Device Record Key: 88117cb2-aa6a-4ad6-9b58-2b0427fc783b

Device Description

The Dropsafe® Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

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
FMF	Syringe, Piston	General Hospital	880.5860	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15907996099969	GS1	shelf box	100	In Commercial Distribution
Primary	05907996099962	GS1
Package	25907996099966	GS1	shipper box	8	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123684	000