Silicone Endo-Drain Kit

GUDID 04710961935834

FORTUNE MEDICAL INSTRUMENT CORP.

Closed-wound drain

• Primary Device ID: 04710961935834
• NIH Device Record Key: 5131c6b4-2203-4d48-9889-68d5dfcf8245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Endo-Drain Kit
• Version Model Number: 2015-9619
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710961935834 [Unit of Use]
GS1	14710961935831 [Primary]

FDA Product Code

• GCD: Connector, Catheter

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: 2022-01-17
• Device Publish Date: 2022-01-07

On-Brand Devices [Silicone Endo-Drain Kit]

• 04711182605551: 2015-9629
• 04711182605544: 2015-9624
• 04710961935841: 2015-9621
• 04710961935834: 2015-9619
• 04710961935827: 2015-9615
• 04710961935810: 2015-9610