FDA.report

OPTICAL COHERENCE TOMOGRAPHY

Primary DI
04987669100516
Brand
OPTICAL COHERENCE TOMOGRAPHY
Company
NIDEK CO.,LTD.
Model
RS-3000 Advance
Device description
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of th
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OBOTomography, Optical Coherence

Product Code Classifications

CodeDeviceSpecialtyClass
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04987669100516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04987669100516049876691005164987669100516

GMDN Terms

TermDefinition
Direct ophthalmoscope, line-poweredA mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags

DUNS number
690635461
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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Other Devices Sharing Product Codes

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04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
04059237000754ANTERIONHeidelberg Engineering GmbHOBO2022-02-14
04059237000617ANTERIONHeidelberg Engineering GmbHOBO2022-01-03
00850003069302IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-12-09
00850003069241IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-06-23
00857691006336ENFOCUS 2300 VHR 100VBIOPTIGEN, INC.OBO2020-06-01
00857691006343ENFOCUS 4400 VHR 100VBIOPTIGEN, INC.OBO2020-06-01
03615020000489OCT500ESSILOR INTERNATIONALOBO2020-03-23
04057748087141CIRRUS HD-OCT Carl Zeiss Meditec, Inc.OBO2019-11-01
00858848006704RTVue XR AvantiOPTOVUE, INC.OBO2019-09-20
00850003069166IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2019-09-19
00850003069203IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2019-09-19
08800019600473Optical Coherence Tomography HOCT-1Huvitz Co., Ltd.OBO2019-05-10
08800019600497Optical Coherence Tomography HOCT-1FHuvitz Co., Ltd.OBO2019-05-10
00850003069074IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2019-04-24
04059237000594SPECTRALISHeidelberg Engineering GmbHOBO2019-04-23
00850003069029IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2019-02-13
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04059237000501SPECTRALISHeidelberg Engineering GmbHOBO2019-01-03
00858848006469RTVue XR AvantiOPTOVUE, INC.OBO2018-12-14
04059237000341SPECTRALISHeidelberg Engineering GmbHOBO2018-07-11