LEADER, pen needles

Basic Information

• Brand Name: LEADER, pen needles
• Primary DI: 00096295138788
• Version / Model: 33G x 4 mm
• Catalog Number: 8472
• Company Name: HTL STREFA S A
• Labeler DUNS: 422528088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-01-13
• Public Version: 1
• Public Version Date: 2020-01-21
• Public Version Status: New
• Public Device Record Key: ee945f69-67d8-4c46-b9bf-3a6071bd4fd5

Device Description

Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00096295138788	GS1
Unit of Use	80096295138784	GS1
Package	50096295138783	GS1	Shipper	12	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			33G x 5/32" | 0.20mm x 4mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius