FDA.reportPublic FDA data

NA

Primary DI
20845854051433
Brand
NA
Company
Conmed Corporation
Model
60-6102-002
Catalog number
60-6102-002
Device description
28.6 mm Disposable Bipolar Cord, 12 ft. (3.6 m)
Published
2020-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
K831236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831236000BIPOLAR CARDNew England Surgical Instrument Corp.1983-06-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854051433PackageGS110In Commercial Distribution
10845854051436PrimaryGS10
00845854051439Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585405143320845854051433
1084585405143610845854051436
00845854051439008458540514398458540514390845854051439

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18