IEC NEUTRAL PAD

Primary DI
00841494105167
Brand
IEC NEUTRAL PAD
Company
Cynosure, LLC
Model
IEC-NPD
Catalog number
IEC-NPD
Device description
IEC NEUTRAL PAD, DISPOSABLE, 25/PKG.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODRElectrosurgical patient return electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODRElectrosurgical Patient Return ElectrodeGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123366000SURGITRON 4.0 DUAL RF S5-IECEllman International, Inc.2013-07-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494105167PrimaryGS10
10841494105164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494105167008414941051678414941051670841494105167
1084149410516410841494105164

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
25
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100032SculpSure laser assembly100-7026-0102017-07-26
00841494100049SculpSure Applicator100-7026-1002017-07-26
00841494106867SculpSure Applicator, RefurbishedR100-7026-1002017-07-24
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUB100-7026-8162017-09-26
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLY100-7026-9102017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL100-7026-9202017-11-29
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYR100-7026-9102018-01-18
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841494108434EXTRA-LARGE GROUNDING PADCynosure, LLCODR2020-01-31
10841494108431EXTRA-LARGE GROUNDING PAD, 25 PCSCynosure, LLCODR2020-01-31
B3702613910Cameron-MillerCAMERON-MILLER INCODR2017-02-11
00841494107130Neutral PadCynosure, LLCODR2017-01-30
GYNX218091Patient Dispercive PadGYNEX CORPORATIONODR2016-10-10
GYNX337141Patient Dispersive PadGYNEX CORPORATIONODR2016-10-10
GYNX60101Patient Dispersive PadGYNEX CORPORATIONODR2016-10-10
00841645103974ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONODR2016-09-25
00841494103484IEC NEUTRAL PLATECynosure, LLCODR2016-09-21
00841494105273NEUTRAL PADCynosure, LLCODR2016-09-21