EXEL 0.3mL INS SYR 28GX1/2" 26017

GUDID 10020221260172

EXEL 0.3mL INS SYR 28GX1/2", 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: 10020221260172
• NIH Device Record Key: c112360b-19c8-4d81-ab29-a09d92b00fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 0.3mL INS SYR 28GX1/2"
• Version Model Number: 26017
• Catalog Number: 26017
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221260175 [Primary]
GS1	10020221260172 [Package]; Contains: 00020221260175; Package: Bag [10 Units]; In Commercial Distribution
GS1	20020221260179 [Package]; Package: Inner box [10 Units]; In Commercial Distribution
GS1	30020221260176 [Package]; Contains: 20020221260179; Package: Outer box [5 Units]; In Commercial Distribution
GS1	40020221260173 [Package]; Contains: 30020221260176; 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: 2023-03-28
• Device Publish Date: 2023-03-20

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