Coblation AC4340-01
GUDID 00817470003314
COVATOR
Smith & Nephew, Inc.
Universal foot-controlled electrosurgical diathermy system conducting unit, single-use| Primary Device ID | 00817470003314 |
| NIH Device Record Key | d9bc5b29-5b4b-4b44-a2f7-a0c137ba9091 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coblation |
| Version Model Number | AC4340-01 |
| Catalog Number | AC4340-01 |
| 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 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817470003314 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033584
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 |
Trademark Results [Coblation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COBLATION 75583142 not registered Dead/Abandoned |
ArthroCare Corporation 1998-11-05 |
 COBLATION 75377654 2279941 Live/Registered |
ArthroCare Corporation 1997-10-22 |
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