FDA.reportPublic FDA data

ERBE

Primary DI
08809083941727
Brand
ERBE
Company
BIOPROTECH INC.
Model
20190-163
Catalog number
20190-163
Device description
rocker switch; holster; spatula electrode; L 3m
Published
2019-03-08
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092732000PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809083941724PackageGS125In Commercial Distribution
28809083941721PackageGS12In Commercial Distribution
08809083941727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880908394172418809083941724
2880908394172128809083941721
08809083941727088090839417278809083941727

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
688460539
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809083949129TELECTRODET8172026-04-30
08809083949136TELECTRODET817A2026-04-30
00858563006256MAX-IFIF40002025-10-13
08809083946883PROPLATE9572C2025-05-20
18809083946880PROPLATE9572C2025-05-20
00815842021386IMCO2030-IMC2025-05-16
10815842021383IMCO2030-IMC2025-05-16
00851255007043Dynamic DIAGNOSTICS, INCPEN112025-03-12
00851255007098Dynamic DIAGNOSTICS, INCPEN312025-03-12
00851255007104Dynamic DIAGNOSTICS, INCPEN212025-03-12
00851255007111Dynamic DIAGNOSTICS, INCPEN412025-03-12
00851255007128Dynamic DIAGNOSTICS, INCP9551F2025-03-12
00851255007135Dynamic DIAGNOSTICS, INCP9552F2025-03-12
00851255007142Dynamic DIAGNOSTICS, INC9551F2025-03-12
00851255007159Dynamic DIAGNOSTICS, INC9552F2025-03-12
00851255007166Dynamic DIAGNOSTICS, INCP9551-RF2025-03-12
20851255007047Dynamic DIAGNOSTICS, INCPEN112025-03-12
00851255007050Dynamic DIAGNOSTICS, INCPEN11NS2025-03-12
00851255007067Dynamic DIAGNOSTICS, INCPEN31NS2025-03-12
00851255007074Dynamic DIAGNOSTICS, INCPEN21NS2025-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03