FDA UDI
In Commercial Distribution
🇺🇸 United States
OCT Ophthalmoscope
DI: 05057056107509
·
Model: P200TxE
·
OPTOS PUBLIC LIMITED COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OCT Ophthalmoscope
- Primary DI
- 05057056107509
- Version / Model
- P200TxE
- Catalog Number
- A10750
- Company Name
- OPTOS PUBLIC LIMITED COMPANY
- Labeler DUNS
- 346013337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-29
- Public Version
- 1
- Public Version Date
- 2019-11-06
- Public Version Status
- New
- Public Device Record Key
- e22328b6-592c-42a3-98c4-5c5b8c40ed35
Device Description
A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.
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
- No
- 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 |
|---|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | Ophthalmic | 886.1570 | 2 |
| OBO | Tomography, Optical Coherence | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64004 | Scanning-laser ophthalmoscope/retinal optical coherence tomography system | An ophthalmic digital image capturing/processing device that is a combination of a scanning-laser ophthalmic imaging system and a retinal optical coherence tomography system intended to: 1) use a low power laser to generate and capture digital confocal images, 2) use a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement, of the retina and associated structures to diagnose and manage retinal diseases. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05057056107509 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190732 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 570 | Millimeter | |
| Width | 540 | Millimeter | |
| Height | 683 | Millimeter |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius