FDA.reportPublic FDA data

Lapbag

Primary DI
08806182216657
Brand
Lapbag
Company
Sejong Medical Co., Ltd
Model
B11-1005
Catalog number
B11-1005
Published
2018-04-06
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
K171726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171726000LapBagSejong Medical Co., Ltd.2017-09-25GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18806182216654PackageGS110In Commercial Distribution
78806182216656PackageGS110In Commercial Distribution
88806182216653PackageGS18In Commercial Distribution
08806182216657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880618221665418806182216654
7880618221665678806182216656
8880618221665388806182216653
08806182216657088061822166578806182216657

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
07613327311839Connect OR OSSTRYKER CORPORATIONGCJ2017-06-30
07613327311846Connected OR OSSTRYKER CORPORATIONGCJ2017-06-30
08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463133symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463140symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463157symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463164symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
10080196000746MedlineMEDLINE INDUSTRIES, INC.GCJ2016-10-14
08714729268642RX ERCP CannulaBOSTON SCIENTIFIC CORPORATIONGCJ2016-09-24