Silicone T Drainage Set

GUDID 04711182613006

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain

• Primary Device ID: 04711182613006
• NIH Device Record Key: 1c5072bf-3f33-4433-b227-5d6fc88aba25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone T Drainage Set
• Version Model Number: 1910-8022
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 5
• 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	04711182613006 [Primary]
GS1	14711182613003 [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 Set]

• 04711182613051: 1910-8012
• 04711182613044: 1910-8014
• 04711182613037: 1910-8016
• 04711182613020: 1910-8018
• 04711182613013: 1910-8020
• 04711182613006: 1910-8022
• 04711182612993: 1910-8024