Silicone Y Drainage Tube

GUDID 04710961934431

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain

• Primary Device ID: 04710961934431
• NIH Device Record Key: 5cbe6264-671f-4a6f-8faa-f1a5df73a123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Y Drainage Tube
• Version Model Number: 1920-0014
• 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	04710961934431 [Primary]
GS1	14710961934438 [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: 2016-03-25

On-Brand Devices [Silicone Y Drainage Tube]

• 04710961934486: 1920-0024
• 04710961934479: 1920-0022
• 04710961934462: 1920-0020
• 04710961934455: 1920-0018
• 04710961934448: 1920-0016
• 04710961934431: 1920-0014