Silicone T Drainage Set With Eyes

GUDID 04711182606428

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain

• Primary Device ID: 04711182606428
• NIH Device Record Key: d0bb8493-0da7-4d14-8bff-8fc3a8a3c6fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone T Drainage Set With Eyes
• Version Model Number: 1910-8214
• 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	04711182606428 [Primary]
GS1	14711182606425 [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 With Eyes]

• 04711182609238: 1910-8218
• 04711182607548: 1910-8212
• 04711182607425: 1910-4005
• 04711182607418: 1910-4008
• 04711182607401: 1910-4010
• 04711182606435: 1910-8216
• 04711182606428: 1910-8214
• 14711182608313: 1910-8224
• 14711182608306: 1910-8220