ENT Sinus 650-60100S

GUDID 00817470009729

VENTERA SINUS DILATION BALLOON 1-PACK

Smith & Nephew, Inc.

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter

• Primary Device ID: 00817470009729
• NIH Device Record Key: fb947dd9-b952-4f4b-b82d-86478ec838e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENT Sinus
• Version Model Number: 650-60100S
• Catalog Number: 650-60100S
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470009729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121351

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL 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: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [ENT Sinus]

• 00817470011869: SERPENT STERILIZATION TRAY LID
• 00817470011845: SERPENT STERILIZATION TRAY BASE
• 20817470009761: MEDIENT MIDDLE TURBINATE IMPLANT 4-PACK
• 00817470009750: MediENT Middle Turbinate Implant 1-pack
• 00817470009729: VENTERA SINUS DILATION BALLOON 1-PACK
• 00817470006469: ENTACT SEPTAL STAPLER 1-PACK
• 20817470006456: ENTACT SEPTAL STAPLER 3-PACK
• 00885556724736: SERPENT STERILIZATION TRAY LID