FDA.reportPublic FDA data

Side load bipolar electrode

Primary DI
03760263240014
Brand
Side load bipolar electrode
Company
CHIRURGIE INNOVATION
Model
Bipolar cutting loop / THICK
Catalog number
MV2S
Device description
(square fitting ; Fr26)
Published
2019-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
03760263240014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760263240014037602632400143760263240014

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264592326
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760263240007Side load bipolar electrodeBipolar cutting loop / THINMV1S2019-10-09
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
03760263240106Working element for SIDE load bipolar electrodeActive working element STORZ compatibleVA1S2019-10-09
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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