FDA.reportPublic FDA data

MONOPOLAR CABLE

Primary DI
B09926951050
Brand
MONOPOLAR CABLE
Company
SONTEC INSTRUMENTS, INC.
Model
2695-105
Device description
MONOPOLAR CABLE
Published
2016-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B09926951050PreviousHIBCC0
00192896005440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896005440001928960054401928960054400192896005440

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length3Meter

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03
00192896099753LUXATOR ELEVATOR1100-586S11100-586S12018-09-21
00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
00192896081635LUXATOR ELEVATOR1100-586C11100-586C12018-09-21
00192896081642LUXATOR ELEVATOR1100-586C21100-586C22018-09-21

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Primary DI, Brand, Company table
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07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
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07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10