FDA.reportPublic FDA data

Electrode SMART

Primary DI
08809495931347
Brand
Electrode SMART
Company
Chungwoo Co., Ltd.
Model
2X180
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222709000Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.2023-03-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809495931347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809495931347088094959313478809495931347

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, reusableA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+8207052091112cwqc@mycw.co.kr

Regulatory Flags#

DUNS number
689894533
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809495931309Hand Piece Electrode LIFTAE20-802024-08-30
08809495931316Hand Piece Electrode SMARTAE20-1802024-08-30
08809495931323Hand Piece Electrode LIPOAE40-3002024-08-30
08809495931330Electrode LIFT2X802024-08-30
08809495931354Electrode LIPO4X3002024-08-30
08809495931361Hand Piece LIFTHP20-802024-08-30
08809495931378Hand Piece SMARTHP20-1802024-08-30
08809495931385Hand Piece LIPOHP40-3002024-08-30
08809495930760Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S142024-06-25
08809495930777Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S252024-06-25
08809495930784Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-S492024-06-25
08809495930791Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C142024-06-25
08809495930807Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C252024-06-25
08809495930814Sterile Micro Needle ELLISYS STCWM-930S_ELLISYS ST-C492024-06-25
08809495931071FIXER DV9CWM-930S2024-06-25
08809495931088ELLISYS SENSECWM-930S2024-06-25
08809495931101FOOT SwitchCWM-910T-H212024-06-25
08809495931132FOOT SwitchCWM-930S-H132024-06-25
08809495931194Neutral CableCWM-910T-H22-12024-06-25
08809495931200Neutral Pad9541C2024-06-25

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Primary DI, Brand, Company table
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