DIGITAL MEDICAL SCOPE

Primary DI
04987669101018
Brand
DIGITAL MEDICAL SCOPE
Company
NIDEK CO.,LTD.
Model
DS-10A
Device description
DS-10A is a digital hand-held anterior scope used to record digital photographs and video of anterior area of the human eye and surrounding area.
Published
2017-01-27
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
FXFSpeculum, Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXFSpeculum, IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669101018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669101018049876691010184987669101018

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, digitalAn electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690635461
Device count
1
Premarket exempt
true
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
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31
04987669101049DIGITAL MEDICAL SCOPEDS-10G2017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811117106INKAThe Trustee for KAISER FAMILY TRUSTFXF2025-12-01
10097604712429Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXF2022-10-28
00025715697550EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
20025715697554EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
00050428387443CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
10050428387440CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
04987669101049DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101070DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31