LEADER, pen needles 8898

GUDID 10096295143000

LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection of drugs.

HTL STREFA S A

Autoinjector needle

• Primary Device ID: 10096295143000
• NIH Device Record Key: 923858b7-2b60-4e86-9a8d-5044adffb956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEADER, pen needles
• Version Model Number: 31G x 8 mm
• Catalog Number: 8898
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 50
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295143003 [Primary]
GS1	10096295143000 [Unit of Use]
GS1	50096295143008 [Package]; Contains: 00096295143003; Package: shipper box [50 Units]; In Commercial Distribution

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: 2024-01-25
• Device Publish Date: 2024-01-17

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