Silicone T Drainage Tube

GUDID 04710961934349

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain

• Primary Device ID: 04710961934349
• NIH Device Record Key: 61b9ace4-2c78-407f-a793-e0c9560a37ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone T Drainage Tube
• Version Model Number: 1910-0024
• 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	04710961934349 [Primary]
GS1	14710961934346 [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]

• 04711182607432: 1910-0005
• 04710961934349: 1910-0024
• 04710961934332: 1910-0022
• 04710961934325: 1910-0020
• 04710961934318: 1910-0018
• 04710961934301: 1910-0016
• 04710961934295: 1910-0014
• 04710961934288: 1910-0012
• 04710961934271: 1910-0010
• 04710961934264: 1910-0008