EXEL 2-3mL SYR 18GX1-1/2" L-L, W/ LDS, 26110BST

GUDID 10020221861102

EXEL 2-3mL SYR 18GX1-1/2" L-L, W/ LDS, 20/TRAY, 100/BX, 1,500/CS

Exel International

General-purpose syringe/needle

• Primary Device ID: 10020221861102
• NIH Device Record Key: 85a3d000-dce7-44cc-8019-1ae6a2b3c1a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 2-3mL SYR 18GX1-1/2" L-L, W/ LDS,
• Version Model Number: 26110BST
• Catalog Number: 26110BST
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221861105 [Primary]
GS1	10020221861102 [Package]; Contains: 00020221861105; Package: Tray [20 Units]; In Commercial Distribution
GS1	20020221861109 [Package]; Package: Inner box [5 Units]; In Commercial Distribution
GS1	30020221861106 [Package]; Contains: 20020221861109; Package: Shipping carton [15 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: 2023-04-12
• Device Publish Date: 2023-04-04

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• 20020221260056 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/3
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• 00020221277685 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube