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 Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle 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