FDA UDI
In Commercial Distribution
🇺🇸 United States
OPTOS ADVANCE
DI: 05057056905709
·
Model: S90570
·
OPTOS PUBLIC LIMITED COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OPTOS ADVANCE
- Primary DI
- 05057056905709
- Version / Model
- S90570
- Company Name
- OPTOS PUBLIC LIMITED COMPANY
- Labeler DUNS
- 346013337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-27
- Public Version
- 6
- Public Version Date
- 2024-04-17
- Public Version Status
- Update
- Public Device Record Key
- 07a76e72-532e-4882-87b5-a0f9031f92c7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63764 | Ophthalmology PACS software | A software program intended to be used primarily as a picture archiving and communication system (PACS) to allow storage, retrieval, and management of digital images of the eye. It may be web-based or installed on a central server for access by a healthcare professional; some types include features for image analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05057056905709 | GS1 |