Spect Ophthalmic Camera

Primary DI
00853501008002
Brand
Spect Ophthalmic Camera
Company
Spect Inc.
Model
BOM001
Device description
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Published
2023-08-10
Public version status
New
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

Product Codes

CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications

CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853501008002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853501008002008535010080028535010080020853501008002

GMDN Terms

TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081054015
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

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