FDA.reportPublic FDA data

CATHAY

Primary DI
16959006303299
Brand
CATHAY
Company
CATHAY MANUFACTURING CORP.
Model
GP202S-AC
Device description
Bipolar Adult Grounding Pad with Cable
Published
2020-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

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
K130027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130027000DISPOSABLE NEUTRAL ELECTRODE GP202Cathay Manufacturing Corp.2013-08-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959006303299PackageGS18In Commercial Distribution
06959006303292PrimaryGS10
26959006303296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695900630329916959006303299
06959006303292069590063032926959006303292
2695900630329626959006303296

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA 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 leads. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+862157878328176541381@qq.com

Regulatory Flags#

DUNS number
421287342
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959006303315AcuZoneAcuZone-40-2x4pigtail electrodes2020-11-13
06959006303322AcuZoneAcuZone-44-2x2 pigtail electrodes2020-11-13
06959006303339AcuZoneAcuZone-40-2x2SNAP electrodes2020-11-13
06959006303308AngelAngel-40-2x2 pigtails electrodes2020-11-13
06959006300437CathayGP202S-AB2024-06-19
06959006300444CathayGP202D-AB2024-06-19
06959006300451CathayGP202S-PB2024-06-19
06959006300468CathayGP202D-PB2024-06-19
06959006300475CathayGP202S-IB2024-06-19
06959006300482CathayGP202D-IB2024-06-19
06959006300505CathayGP202D-TB2023-10-08
06959006300772CathayGP202S-PCB2023-10-08
06959006300789CathayGP202D-PCB2023-10-08
06959006300819CathayGP202S-TCB2023-10-08
06959006300826CathayGP202D-TCB2023-10-08
06959006302981CathayCP10012023-10-08
06959006304404CathayGP202S-TCB2023-10-08
06959006304411CathayGP202D-TCB2023-10-08
06959006300499CathayGP202S-TB2023-10-08
16959006300502CathayGP202D-TB2023-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12
00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09
00190776434199MillenniumAvalign Technologies, Inc.GEI2026-10-09
B382SD030861101530Surgical DirectSurgical Direct, Inc.GEI2026-10-09
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215410Disposable Bipolar Forceps, 9", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05