SMART FLEX SF10100SB

GUDID 20705032065785

SMART FLEX 10x100 BIL80cm

Cordis US Corp.

Bare-metal biliary stent

• Primary Device ID: 20705032065785
• NIH Device Record Key: 47433eb7-c40f-4039-9c4e-7b46fa9dda97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART FLEX
• Version Model Number: SF10100SB
• Catalog Number: SF10100SB
• Company DUNS: 118274128
• Company Name: Cordis US Corp.
• 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	20705032065785 [Primary]

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: 2024-03-04
• Device Publish Date: 2024-02-23

On-Brand Devices [SMART FLEX]

• 20705032066348: SMART FLEX 8x120 BIL, 120cm
• 20705032066317: SMART FLEX 10x100 BIL120cm
• 20705032066263: SMART FLEX 9x60 BIL120cm
• 20705032066256: SMART FLEX 8x40 BIL, 120cm
• 20705032066249: SMART FLEX 5x40 BIL, 120cm
• 20705032066225: SMART FLEX 5x30 BIL, 120cm
• 20705032066188: SMART FLEX 10x30 BIL120cm
• 20705032066096: SMART FLEX 9x80 BIL120cm
• 20705032066065: SMART FLEX 8x60 BIL, 120cm
• 20705032066058: SMART FLEX 7x60 BIL, 120cm
• 20705032066041: SMART FLEX 6x60 BIL, 120cm
• 20705032066034: SMART FLEX 6x150 BIL, 120cm
• 20705032066003: SMART FLEX 5x60 BIL, 120cm
• 20705032065952: SMART FLEX 10x60 BIL120cm
• 20705032065945: SMART FLEX 10x60 BIL80cm
• 20705032065921: SMART FLEX 7x40 BIL, 120cm
• 20705032065914: SMART FLEX 6x40 BIL, 120cm
• 20705032065907: SMART FLEX 8x40 BIL, 80cm
• 20705032065853: SMART FLEX 9x40 BIL120cm
• 20705032065792: SMART FLEX 9x100 BIL120cm
• 20705032065778: SMART FLEX 9x100 BIL80cm
• 20705032065747: SMART FLEX 7x80 BIL, 120cm
• 20705032065730: SMART FLEX 7x120 BIL, 120cm
• 20705032065723: SMART FLEX 6x120 BIL, 120cm
• 20705032065655: SMART FLEX 7x100 BIL, 120cm
• 20705032065648: SMART FLEX 6x100 BIL, 120cm
• 20705032065624: SMART FLEX 8x150 BIL, 120cm
• 20705032065617: SMART FLEX 7x150 BIL, 120cm
• 20705032065600: SMART FLEX 5x100 BIL, 120cm
• 20705032065594: SMART FLEX 6x80 BIL, 120cm
• 20705032065587: SMART FLEX 5x80 BIL, 120cm
• 20705032065570: SMART FLEX 10x40 BIL80cm
• 20705032065563: SMART FLEX 9x40 BIL80cm
• 20705032066171: SMART FLEX 9x30 BIL120cm
• 20705032065990: SMART FLEX 8x60 BIL, 80cm
• 20705032065938: SMART FLEX 9x60 BIL80cm
• 20705032065785: SMART FLEX 10x100 BIL80cm
• 20705032065716: SMART FLEX 5x120 BIL, 120cm
• 20705032065662: SMART FLEX 8x100 BIL, 120cm