FDA.reportPublic FDA data

Neutral Pad

Primary DI
00841494107130
Brand
Neutral Pad
Company
Cynosure, LLC
Model
IEC-NPD1
Catalog number
IEC-NPD1
Device description
IEC NEUTRAL PAD, DISPOSABLE, 1/PKG
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00841494107130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494107130008414941071308414941071300841494107130

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-use, sterileA sterile dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

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
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
00841494105167IEC NEUTRAL PADCynosure, LLCODR2016-09-21
00841494105273NEUTRAL PADCynosure, LLCODR2016-09-21