EXEL 0.3mL INS SYR 30GX1/2" 26019

GUDID 10020221260196

EXEL 0.3mL INS SYR 30GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN

Exel International

Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: 10020221260196
• NIH Device Record Key: 2e3e6cdb-1c48-4a80-b6fa-b2d807dc19a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 0.3mL INS SYR 30GX1/2"
• Version Model Number: 26019
• Catalog Number: 26019
• Company DUNS: 180572216
• Company Name: Exel International
• Device Count: 1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221260199 [Primary]
GS1	10020221260196 [Package]; Contains: 00020221260199; Package: Bag [10 Units]; In Commercial Distribution
GS1	20020221260193 [Package]; Package: Inner box [10 Units]; In Commercial Distribution
GS1	30020221260190 [Package]; Contains: 20020221260193; Package: Outer box [5 Units]; In Commercial Distribution
GS1	40020221260197 [Package]; Contains: 30020221260190; Package: Shipping carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861153

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: 2023-03-22
• Device Publish Date: 2023-03-14

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