LEADER, pen needles 8470

GUDID 50096295138769

Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.

HTL STREFA S A

Autoinjector needle

• Primary Device ID: 50096295138769
• NIH Device Record Key: 5216f365-4fdd-45b6-95ab-98cfbfbf807b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEADER, pen needles
• Version Model Number: 31G x 8 mm
• Catalog Number: 8470
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295138764 [Primary]
GS1	10096295138761 [Unit of Use]
GS1	50096295138769 [Package]; Contains: 00096295138764; Package: shipping box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171982

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2019-12-27
• Device Publish Date: 2019-12-19

On-Brand Devices [LEADER, pen needles]

• 00096295138788: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous
• 50096295138776: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
• 50096295138769: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
• 50096295138752: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
• 50096295138745: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
• 50096295138738: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
• 10096295143000: LEADER pen needles are sterile, single-use pen needles intended for use with pen injector device
• 50096295142995: LEADER pen needles are sterile, single-use pen needles intended for use with pen injector device