FDA.reportPublic FDA data

ITS Model-L

Primary DI
08800033200031
Brand
ITS Model-L
Company
InTheSmart Co., Ltd.
Model
ITSLC1711, ITSLC1721
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FWLCamera, Cine, Endoscopic, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWLCamera, Cine, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800033200031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033200031088000332000318800033200031

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cine cameraAn electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities.

Regulatory Flags#

DUNS number
694495825
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800033200048ITS Model-L6KITSLC1811, ITSLC18212022-11-11
08800033200024ITS Model-LITSEL17112018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319758977Hayden MedicalHayden Medical, Inc.FWL2026-04-23
08908025548083UnivLabs UNIVLABS TECHNOLOGIES PRIVATE LIMITEDFWL2025-07-01
00840319757963Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757970Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757321Hayden MedicalHayden Medical, Inc.FWL2024-06-27
08800033200048ITS Model-L6KInTheSmart Co., Ltd.FWL2022-11-11
00078301211227Health SupportCarolon CompanyFWL2022-10-18
00851289007224Firefly Firefly GlobalFWL2022-09-20
00860006918705ProsidioProsidio LLCFWL2021-06-06
00857326005567FocESSSTRYKER CORPORATIONFWL2020-09-18
00863333000327DUROSCOPEFMD, LLCFWL2019-02-09
00863333000334DUROSCOPEFMD, LLCFWL2019-02-09
00863333000358DUROSCOPEFMD, LLCFWL2019-02-09
86333300030188DUROSCOPEFMD, LLCFWL2019-02-09
86333300030218DUROSCOPEFMD, LLCFWL2019-02-09
86333300030232DUROSCOPEFMD, LLCFWL2019-02-09
B1778020RF0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-10-18
B1778007I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778008I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778009I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778013I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778019I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778020I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780500Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780520Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
00851289007040RedfinFirefly GlobalFWL2018-08-14
00851289007057FireflyFirefly GlobalFWL2018-08-14
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16