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Coblation EIC4835-01

by Smith & Nephew, Inc.

Coblation EIC4835-01 is a Class II device made by Smith & Nephew, Inc., listed in FDA GUDID since 29 Aug 2015 (UDI-DI 00817470005455), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817470005455 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Coblation
Generic name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Model / Ref / Catalog
EIC4835-01
Description
ENT COBLATOR II, REFLEX ULTRA PTR WITH INTEGRATED CABLE
Primary DI / UDI-DI
00817470005455
FDA product code
GEI
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Similar devices in this category

Other devices filed under Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)