EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP

GUDID 10020221263043

EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP

Exel International

General-purpose syringe, single-use

• Primary Device ID: 10020221263043
• NIH Device Record Key: e7872bcd-e797-40d9-acc1-492451e56f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP
• Version Model Number: 26304
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221263046 [Primary]
GS1	10020221263043 [Package]; Contains: 00020221263046; Package: inner box [100 Units]; In Commercial Distribution
GS1	20020221263040 [Package]; Package: Outer 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: 2023-03-17
• Device Publish Date: 2023-03-09

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