FDA.reportPublic FDA data

DIGITAL MEDICAL SCOPE

Primary DI
04987669101070
Brand
DIGITAL MEDICAL SCOPE
Company
NIDEK CO.,LTD.
Model
DS-10 Control Unit
Device description
The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video ofthe body.
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope
FSPLoupe, Diagnostic/Surgical
FTTCamera, Still, Surgical
FXFSpeculum, Illuminated
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1
FTTCamera, Still, SurgicalGeneral, Plastic Surgery1
FXFSpeculum, IlluminatedGeneral, Plastic Surgery1
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669101070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669101070049876691010704987669101070

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorA device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
10857253006085Phoenix ICON GO Control BoxPhoenix ClinicalHKI2026-05-14
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
08034028770517ESSILORVISIA IMAGING SRLHKI2024-11-04
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
08034028770487MYAHVISIA IMAGING SRLHKI2023-10-12
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10615375009601Orascoptic - OmniOptic HDL 3.5METREX RESEARCH, LLCFSP2022-12-08
10615375009618Orascoptic - OmniOptic HDL 4.5METREX RESEARCH, LLCFSP2022-12-08
00615375001158Orascoptic - HDL 2.5 MicroMETREX RESEARCH, LLCFSP2022-12-08
00615375001172Orascoptic - HDL 3.0METREX RESEARCH, LLCFSP2022-12-08
00615375001271Orascoptic - EyeZoomMETREX RESEARCH, LLCFSP2022-12-08
00615375001295Orascoptic - RDH EliteMETREX RESEARCH, LLCFSP2022-12-08
00615375008614Orascoptic - HDL 3.5METREX RESEARCH, LLCFSP2022-12-08
00615375008638Orascoptic - HDL 4.5METREX RESEARCH, LLCFSP2022-12-08
00615375008652Orascoptic - HDL 5.5METREX RESEARCH, LLCFSP2022-12-08
00615375008676Orascoptic - EyeZoom MiniMETREX RESEARCH, LLCFSP2022-12-08
00615375009550Orascoptic - Safety FrameMETREX RESEARCH, LLCFSP2022-12-08
00615375009574Orascoptic - OmniOpticMETREX RESEARCH, LLCFSP2022-12-08
00615375009833Orascoptic - HDL 2.5 Micro RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009857Orascoptic - HDL 3.0 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009956Orascoptic - EyeZoom RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009970Orascoptic - RDH Elite RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010006Orascoptic - HDL 3.5 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010020Orascoptic - HDL 4.5 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010044Orascoptic - HDL 5.5 RxMETREX RESEARCH, LLCFSP2022-12-08