DUROSCOPE

Primary DI
86333300030188
Brand
DUROSCOPE
Company
FMD, LLC
Model
CL 150
Catalog number
CL 150
Device description
Camera control and light source
Published
2019-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
86333300030188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8633330003018886333300030188

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124947339
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00863333000303DUROSCOPELC-0507-BLC-0507-B2017-03-09
00863333000341DUROSCOPELC-0507-CLC-0507-C2017-03-09
00863333000310DUROSCOPE LD 2500LD 25002019-02-09
00863333000327DUROSCOPEHD-101HD-1012019-02-09
00863333000334DUROSCOPEUHD-631UHD-6312019-02-09
00863333000358DUROSCOPECL 150CL 1502019-02-09
86333300030515DUROSCOPELC-0507-BLC-0507-B2017-03-09
86333300030522DUROSCOPELC-0507-CLC-0507-C2017-03-09
86333300030102DUROSCOPE LD 2500LD 25002019-02-09
86333300030218DUROSCOPEHD-101HD-1012019-02-09
86333300030232DUROSCOPEUHD-631UHD-6312019-02-09
86333300030517DUROSCOPELC-0507-BLC-0507-B2017-03-09
86333300030527DUROSCOPELC-0507-CLC-0507-C2017-03-09

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
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
08800033200031ITS Model-LInTheSmart Co., Ltd.FWL2018-06-15
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16