Silicone T Drainage Set

GUDID 04711182612993

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain

• Primary Device ID: 04711182612993
• NIH Device Record Key: b2d37bf2-98b3-488e-b8c8-0d42eca6185c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone T Drainage Set
• Version Model Number: 1910-8024
• 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	04711182612993 [Primary]
GS1	14711182612990 [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