FDA.reportPublic FDA data

EndoGuidance L-Hook Electrode

Primary DI
00810143451207
Brand
EndoGuidance L-Hook Electrode
Company
Medical Disposables Corp
Model
MDPL-33
Device description
MDPL-33 L-Hook Monopolar Electrode 5x33mm
Published
2024-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K142208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142208000Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd.2015-04-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143451207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143451207008101434512078101434512070810143451207

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact 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 ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961673774
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143451733MD DrugScreenMDC-7108-AD2026-03-18
00810143451740MD DrugScreenMDC-7108-AD2026-03-18
00810143451757MD DrugScreenMDC-7108-AD2026-03-18
00860007913167MD DrugScreenMDC-6135F2026-03-18
00810143451603MD DrugScreenMDC-03194AD2025-10-10
00850041101750Onsite DrugScreenODTC-61252023-04-24
00810143451450EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451467EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451474EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451412MD DrugScreenM-DFN-114C2024-09-13
00810143451429MD DrugScreenM-DFN-114C2024-09-13
00810143451443MD DrugScreenM-DFN-114C2024-09-13
00810143451214EndoGuidance L-Hook ElectrodeMDPL-332024-03-19
00810143451221EndoGuidance L-Hook ElectrodeMDPL-332024-03-19
00810143451061MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-12-15
00810143451078MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-12-15
00810143451054MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-11-06
00810143450002MD EndoGuidanceMD5-1002023-07-31
00810143450033MD EndoGuidanceMD10-1002023-07-31
00810143450064MD EndoGuidanceMD12-1002023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26