FDA.reportPublic FDA data

Electrosurgical Unit MCB

Primary DI
03665415002116
Brand
Electrosurgical Unit MCB
Company
LAMIDEY NOURY MEDICAL
Model
V10GMCBUS
Catalog number
V10GMCBUS
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222542000MCB UNIT Model: V10GMCBUSLamidey Noury Medical2022-09-21KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665415002116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665415002116036654150021163665415002116

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33169206969info@lamidey-noury.fr

Regulatory Flags#

DUNS number
266955967
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665415002840Active working element (SIDE load; round ; Fr26 ; WOLF compatible)VA4SVA4S2025-10-08
03665415002857Passive working element (SIDE load; round ; Fr26 ; WOLF compatible)VP4SVP4S2025-10-08
03665415002888Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatVP6SVP6S2025-10-08
03665415002895Active working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatiVA6SVA6S2025-10-08
03665415002772Bipolar cutting loop / SLIM (round; Fr22)MV3SMV3S2025-04-24
03665415002789Bipolar cutting loop / SLIM (round; Fr22)MV3SMV3S2025-04-24
03665415002796Active working element (SIDE load; round ; Fr22 ; STORZ compatible)VA5SVA5S2025-04-24
03665415002802Passive working element (SIDE load; round ; Fr22 ; STORZ compatible)VP5SVP5S2025-04-24
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)MVVSMVVS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)MV2SMV2S2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)MV1SMV1S2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)MVKSMVKS2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)VA3SVA3S2023-04-21
03665415002161Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)VP3SVP3S2023-04-21
03665415002178Active working element (SIDE load; round ; Fr26 ; STORZ compatible)VA1SVA1S2023-04-21
03665415002185Passive working element (SIDE load; round ; Fr26 ; STORZ compatible)VP1SVP1S2023-04-21
03665415002260Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)MVVSMVVS2023-04-21
03665415002284Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)MV2SMV2S2023-04-21
03665415002307Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)MV1SMV1S2023-04-21
03665415002420Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)MVKSMVKS2023-04-21

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