Laport

Primary DI
88806182210330
Brand
Laport
Company
Sejong Medical Co., Ltd
Model
N22-0510
Catalog number
N22-0510
Published
2018-04-05
Public version status
Update
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
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
18806182210331PackageGS110In Commercial Distribution
88806182210330PackageGS18In Commercial Distribution
08806182210334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880618221033118806182210331
8880618221033088806182210330
08806182210334088061822103348806182210334

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689850476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
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
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
88806182210378LaportN21-0510N21-05102018-04-05
88806182210392LaportN21-0575N21-05752018-04-05
08806182210433LaportN21-1110N21-11102018-04-05
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