FDA.reportPublic FDA data

Neutral Pad

Primary DI
08809495931200
Brand
Neutral Pad
Company
Chungwoo Co., Ltd.
Model
9541C
Published
2024-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
08809495931200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809495931200088094959312008809495931200

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827052091112cwqc@mycw.co.kr

Regulatory Flags#

DUNS number
689894533
Device count
1
Lot or batch
true
Expiration date on label
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
08809495931347Electrode SMART2X1802024-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21