EXEL 1/2mL INS SYR 28GX1/2" 26023

GUDID 10020221260233

EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN

Exel International

Insulin syringe/needle, basic

• Primary Device ID: 10020221260233
• NIH Device Record Key: 43f43af9-9b76-48a8-a93d-01f209409e49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 1/2mL INS SYR 28GX1/2"
• Version Model Number: 26023
• Catalog Number: 26023
• 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 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221260236 [Primary]
GS1	10020221260233 [Package]; Contains: 00020221260236; Package: Inner box [100 Units]; In Commercial Distribution
GS1	20020221260230 [Package]; Package: Outer box [5 Units]; In Commercial Distribution
GS1	30020221260237 [Package]; Contains: 20020221260230; 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: 2024-12-03
• Device Publish Date: 2024-11-25

On-Brand Devices [EXEL 1/2mL INS SYR 28GX1/2"]

• 10020221260240: EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN
• 10020221260233: EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN