FDA.reportPublic FDA data

Laport

Primary DI
08806182210433
Brand
Laport
Company
Sejong Medical Co., Ltd
Model
N21-1110
Catalog number
N21-1110
Published
2018-04-05
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171741000LaportSejong Medical Co., Ltd.2017-08-29GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18806182210430PackageGS110In Commercial Distribution
88806182210439PackageGS18In Commercial Distribution
08806182210433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880618221043018806182210430
8880618221043988806182210439
08806182210433088061822104338806182210433

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689850476
Device count
1
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806182210334LaportN22-0510N22-05102018-04-05
08806182210372LaportN21-0510N21-05102018-04-05
08806182210396LaportN21-0575N21-05752018-04-05
08806182210518LaportN23-0575N23-05752018-04-05
08806182210587LaportN23-1210N23-12102018-04-05
08806182210877LaportN20-0510N20-05102018-04-05
88806182210330LaportN22-0510N22-05102018-04-05
88806182210378LaportN21-0510N21-05102018-04-05
88806182210392LaportN21-0575N21-05752018-04-05
88806182210514LaportN23-0575N23-05752018-04-05
88806182210583LaportN23-1210N23-12102018-04-05
88806182210873LaportN20-0510N20-05102018-04-05
08806182216626LapbagB11-1002B11-10022018-04-06
08806182216657LapbagB11-1005B11-10052018-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551158913n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04048551158937n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04251303804093TrokamedTROKAMED GmbHGCJ2026-11-03
04251303804116TrokamedTROKAMED GmbHGCJ2026-11-03
04251303808916TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809036TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809043TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809050TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809067TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809074TrokamedTROKAMED GmbHGCJ2026-11-03
04251303810933TrokamedTROKAMED GmbHGCJ2026-11-03
04251303817611TrokamedTROKAMED GmbHGCJ2026-11-03
04048551431603n.a.Karl Storz GmbH & Co. KGGCJ2026-11-02
08904332600803MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2026-11-02
B382SD13108150Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD15908450Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD32154290Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19