OCT500
Basic Information
- Brand Name
- OCT500
- Primary DI
- 03615020000489
- Version / Model
- OCT2JT
- Company Name
- ESSILOR INTERNATIONAL
- Labeler DUNS
- 277373213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-23
- Public Version
- 1
- Public Version Date
- 2020-03-31
- Public Version Status
- New
- Public Device Record Key
- d167f846-7e1e-4d99-ba2c-e1e858883177
Device Description
3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OBO | Tomography, Optical Coherence | Ophthalmic | 886.1570 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46799 | Retinal optical coherence tomography system | An assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615020000489 | GS1 |
Customer Contacts
- Phone
- +33172947322
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius