EXEL SPINAL NDL 20GX1-1/2" 26963

GUDID 10020221269632

EXEL SPINAL NDL 20GX1-1/2", 50/BOX,100/CS, 4CS/CRTN

Exel International

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• Primary Device ID: 10020221269632
• NIH Device Record Key: c39d1a4e-8fa4-4c6e-9b38-bf575fbe9e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL SPINAL NDL 20GX1-1/2"
• Version Model Number: 26963
• Catalog Number: 26963
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221269635 [Primary]
GS1	10020221269632 [Package]; Contains: 00020221269635; Package: Inner box [50 Units]; In Commercial Distribution
GS1	20020221269639 [Package]; Package: Outer box [2 Units]; In Commercial Distribution
GS1	30020221269636 [Package]; Contains: 20020221269639; Package: Shipping carton [4 Units]; In Commercial Distribution
GS1	40020221269633 [Package]; Package: Shipping carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895771

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-03-24
• Device Publish Date: 2023-03-16

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