Silicone T Drainage Tube With Eyes

GUDID 04710961934394

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain

• Primary Device ID: 04710961934394
• NIH Device Record Key: 4c665d18-80f0-4a50-85e2-2d243d1e8de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone T Drainage Tube With Eyes
• Version Model Number: 1910-0218
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 10
• 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: 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	04710961934394 [Primary]
GS1	14710961934391 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980917

FDA Product Code

• GCA: Catheter, Biliary, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-24

On-Brand Devices [Silicone T Drainage Tube With Eyes]

• 04710961934424: 1910-0224
• 04710961934417: 1910-0222
• 04710961934400: 1910-0220
• 04710961934394: 1910-0218
• 04710961934387: 1910-0216
• 04710961934370: 1910-0214
• 04710961934363: 1910-0212
• 04710961934356: 1910-0210