FDA.reportPublic FDA data

Working element for SIDE load bipolar electrode

Primary DI
03760263240106
Brand
Working element for SIDE load bipolar electrode
Company
CHIRURGIE INNOVATION
Model
Active working element STORZ compatible
Catalog number
VA1S
Device description
(square ; Fr26)
Published
2019-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological
FDCResectoscope, Working Element
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
FDCResectoscope, Working ElementGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760263240106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760263240106037602632401063760263240106

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
264592326
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760263240007Side load bipolar electrodeBipolar cutting loop / THINMV1S2019-10-09
03760263240014Side load bipolar electrodeBipolar cutting loop / THICKMV2S2019-10-09
03760263240021Side load bipolar electrodeBipolar electrode / VAPORIZATIONMVVS2019-10-09
03760263240038Front load bipolar electrodeBipolar cutting loop / THIN OLYMPUS compatibleMV12019-10-09
03760263240045Front load bipolar electrodeBipolar cutting loop / THICK OLYMPUS compatibleMV22019-10-09
03760263240052Front load bipolar electrodeBipolar electrode / VAPORIZATION OLYMPUS compatiblMVV2019-10-09
03760263240069Front load bipolar electrodeBipolar cutting loop / THIN STORZ compatibleMV1Z2019-10-09
03760263240076Front load bipolar electrodeBipolar cutting loop / THICK STORZ compatibleMV2Z2019-10-09
03760263240083Front load bipolar electrodeBipolar electrode / VAPORIZATION STORZ compatibleMVVZ2019-10-09
03760263240090Working element for SIDE load bipolar electrodePassive working element STORZ compatibleVP1S2019-10-09
03760263240113Working element for SIDE load bipolar electrodePassive working element OLYMPUS compatibleVP3S2019-10-09
03760263240120Working element for SIDE load bipolar electrodeActive working element OLYMPUS compatibleVA3S2019-10-09
03760263240137Working element for FRONT load bipolar electrodePassive working element STORZ compatibleVP12019-10-09
03760263240144Working element for FRONT load bipolar electrodeActive working element STORZ compatibleVA12019-10-09
03760263240151Working element for FRONT load bipolar electrodePassive working element OLYMPUS compatibleVP32019-10-09
03760263240168Working element for FRONT load bipolar electrodeActive working element OLYMPUS compatibleVA32019-10-09
03760263240175Working element for FRONT load bipolar electrodePassive working element ACMI compatibleVP42019-10-09
03760263240182Working element for FRONT load bipolar electrodeActive working element ACMI compatibleVA42019-10-09

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