Droplet® insulin syringe 6228

GUDID 10859135002758

droplet insulin syringes with fixed needles is a sterile single use syringe for the injection of U-100 insulin only

HTL STREFA S A

Insulin syringe/needle, basic

• Primary Device ID: 10859135002758
• NIH Device Record Key: af6c8055-d16c-4ec7-b193-a0198ddb9849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Droplet® insulin syringe
• Version Model Number: 1ml, 30G x 8mm
• Catalog Number: 6228
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859135002751 [Primary]
GS1	10859135002758 [Package]; Contains: 00859135002751; Package: shipper box [20 Units]; In Commercial Distribution
GS1	80859135002757 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201044

FDA Product Code

• FMF: Syringe, Piston

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [Droplet® insulin syringe]

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