FDA.reportPublic FDA data

Logi - Laparoscopic Instrument System

Primary DI
05051986007120
Brand
Logi - Laparoscopic Instrument System
Company
SURGICAL INNOVATIONS LIMITED
Model
120-7902
Device description
Logi Curved Dissector 450mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K063485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063485000LOGIC LAPAROSCOPIC SCISSORSSurgical Innovations Plc2006-12-01GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051986011264PackageGS110In Commercial Distribution
05051986007120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051986011264050519860112645051986011264
05051986007120050519860071205051986007120

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.

Regulatory Flags#

DUNS number
771051935
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
05051986013503YelloPort Elite - Laparoscopic Port Access SystemET05055092025-03-11
05051986013510YelloPort Elite - Laparoscopic Port Access SystemET05070092025-03-11
05051986013527YelloPort Elite - Laparoscopic Port Access SystemET05095092025-03-11
05051986013572YelloPort Elite - Laparoscopic Port Access SystemEC13075202024-08-29
05051986013589YelloPort Elite - Laparoscopic Port Access SystemEC13105202024-08-29
05051986013596YelloPort Elite - Laparoscopic Port Access SystemEC13150202024-08-29
05051986001357YelloPort PlusYA516STS2016-09-23
05051986001562YelloPort Elite - Laparoscopic Port Access SystemEA512US2020-10-08
05051986002323YelloPort Plus - Laparoscopic Port Access SystemYA03VSS022020-10-08
05051986012537YelloPort Plus - Laparoscopic Port Access SystemYA03VSS032020-10-08
05051986013077YelloPort Elite EA05XL2022-04-14
05051986000794YelloPort530004S2017-07-10
05051986000831YelloPort550004S2017-07-10
05051986000824YelloPort550004R2016-09-23
05051986001050YelloPort585021S2016-09-23
05051986002286YelloPort Plus - Laparoscopic Port Access SystemYA03VSS012016-09-23
05051986002347YelloPort Plus - Laparoscopic Port Access SystemYA05VSS012016-09-23
05051986002361YelloPort Plus - Laparoscopic Port Access SystemYA05VSS022016-09-23
05051986002385YelloPort Plus - Laparoscopic Port Access SystemYA05VSS032016-09-23
05051986002408YelloPort Plus - Laparoscopic Port Access SystemYA510STSA2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14