FDA.reportPublic FDA data

Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compat

Primary DI
03665415002888
Brand
Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compat
Company
LAMIDEY NOURY MEDICAL
Model
VP6S
Catalog number
VP6S
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240504000PLASMA EDGE SystemLamidey Noury Medical2024-06-12FAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665415002888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665415002888036654150028883665415002888

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

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03665415002840Active working element (SIDE load; round ; Fr26 ; WOLF compatible)VA4SVA4S2025-10-08
03665415002857Passive working element (SIDE load; round ; Fr26 ; WOLF compatible)VP4SVP4S2025-10-08
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
03665415002116Electrosurgical Unit MCBV10GMCBUSV10GMCBUS2023-04-21
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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