Coblation AC4045-01

GUDID 00817470003116

TOPAZ XL ICW

Smith & Nephew, Inc.

Universal foot-controlled electrosurgical diathermy system conducting unit, single-use

• Primary Device ID: 00817470003116
• NIH Device Record Key: c6b0c172-09a7-47a1-bdab-48cea6c7df81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coblation
• Version Model Number: AC4045-01
• Catalog Number: AC4045-01
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470003116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080282

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [Coblation]

• 00817470012217: RF20000A REFURBISHED CONTROLLER W/ ACC
• 00817470009743: PROCISE XP COBLATOR II
• 20817470008993: CATALOG NUMBER SAP TUBE CLIP
• 00817470007503: CIQ PERC DC
• 00817470007497: CIQ PERC DLG
• 00817470007480: CIQ PERC DLR
• 00817470007473: PROCISE MAX COBLATOR II
• 00817470006551: AMBIENT SUPER MULTIVAC 50 IFS
• 00817470006520: TURBOVAC 90 XL ICW
• 00817470006506: SUPER TURBOVAC 90 IFS
• 00817470006445: HEAD & NECK WAND COBLATOR II
• 00817470006421: SUPER TURBOVAC 90 ICW
• 00817470006285: CAT 8IN 17G CRAWFORD CANNULA
• 00817470006278: CAT 6IN 17G CRAWFORD CANNULA
• 00817470006261: MULTIVAC 50 XL ICW
• 00817470006186: REFLEX ULTRA SP COBLATOR II
• 00817470006162: PERC DC
• 00817470005479: TOPAZ XL IFS
• 00817470005462: TOPAZ IFS
• 00817470005455: REFLEX ULTRA PTR COBLATOR II
• 00817470005240: TURBINATOR COBLATOR II
• 00817470004908: SUPER MULTIVAC 50 IFS
• 00817470004854: SABER 30 DEGREE ICW
• 00817470004700: COVAC 70 ICW
• 00817470004595: EVAC 70 XTRA HP COBLATOR II
• 00817470004588: SYSTEM 2000 FOOT CONTROL
• 00817470004564: 2.3MM SHORT BEVEL 35 DEGREE ICW
• 00817470004557: 2.5MM DOME 60 DEGREE ICW
• 00817470004540: BEVEL 45 ICW
• 00817470004533: LOPRO ICW
• 00817470004489: PERC DLG
• 00817470004472: PERC DLR
• 00817470004441: POWER CORD 20 FT. DOMESTIC
• 00817470004335: PROCISE EZ VIEW COBLATOR II
• 00817470004328: REFLEX ULTRA SP COBLATOR II
• 00817470004311: PROCISE MINI LARYNGEAL COBLATOR II
• 00817470004274: SYSTEM 2000 CONTROLLER (120V)
• 00817470004243: PROCISE LW COBLATOR II
• 00817470004236: CAVITY 8 GAUGE
• 00817470004212: REFLEX ULTRA 45 COBLATOR II
• 00817470004199: REFLEX ULTRA 55 COBLATOR II
• 00817470004182: IRRIGATION PUMP CONTROLLER (120V)
• 00817470004151: PROCISE EZ COBLATOR II
• 00817470004007: EVAC 70 XTRA HP COBLATOR II
• 00817470003888: PROCISE MAX COBLATOR II
• 00817470003871: REFLEX ULTRA PTR COBLATOR II
• 00817470003734: REFLEX ULTRA 45 COBLATOR II
• 00817470003710: EVAC 70 XTRA COBLATOR II
• 00817470003574: TOPAZ EZ IFS
• 00817470003567: EVAC BENDING TOOL