FDA.reportPublic FDA data

Victan

Primary DI
16956989913293
Brand
Victan
Company
Jiangsu Haize Medical Scientific Development Co.,Ltd.
Model
EC-GN435H
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K230593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230593000VictanJiangsu Haize Medical Scientific Development Co., Ltd.2023-05-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16956989913293PackageGS15In Commercial Distribution
26956989913290PackageGS16In Commercial Distribution
06956989913296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695698991329316956989913293
2695698991329026956989913290
06956989913296069569899132966956989913296

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421332708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06956989913326VictanEC-PT190H 2023-06-15
06956989913333VictanEC-PN335H 2023-06-15
06956989913340VictanEC-PT335H 2023-06-15
06956989913357VictanEC-PN435H 2023-06-15
06956989913364VictanEC-PT435H 2023-06-15
06956989913371VictanEC-GN190N 2023-06-15
06956989913388VictanEC-GT190N 2023-06-15
06956989913395VictanEC-GN335N 2023-06-15
06956989913401VictanEC-GT335N 2023-06-15
06956989913418VictanEC-GN435N 2023-06-15
06956989913425VictanEC-GT435N 2023-06-15
06956989913432VictanEC-PN190N 2023-06-15
06956989913449VictanEC-PT190N 2023-06-15
06956989913456VictanEC-PN335N 2023-06-15
06956989913463VictanEC-PT335N 2023-06-15
06956989913470VictanEC-PN435N 2023-06-15
06956989913487VictanEC-PT435N 2023-06-15
16956989913323VictanEC-PT190H 2023-06-15
16956989913330VictanEC-PN335H 2023-06-15
16956989913347VictanEC-PT335H 2023-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
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07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10