SMART FLEX SF10030SB

GUDID 20705032065839

SMART FLEX 10x30 BIL80cm

CORDIS CORPORATION

Bare-metal biliary stent

• Primary Device ID: 20705032065839
• NIH Device Record Key: cc2d69db-b096-4eb0-9b4c-adfcb70d987a
• Commercial Distribution Discontinuation: 2024-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SMART FLEX
• Version Model Number: SF10030SB
• Catalog Number: SF10030SB
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705032065832 [Primary]
GS1	20705032065839 [Package]; Contains: 10705032065832; Package: Box [1 Units]; Discontinued: 2024-07-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121125

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [SMART FLEX]

• 20705032066218: SMART FLEX 8x30 BIL, 80cm
• 20705032066164: SMART FLEX 9x30 BIL80cm
• 20705032065846: SMART FLEX 7x30 BIL, 120cm
• 20705032065839: SMART FLEX 10x30 BIL80cm
• 20705032065631: SMART FLEX 8x30 BIL, 120cm