FDA UDI
In Commercial Distribution
🇺🇸 United States
ClarifEye
DI: 00884838104570
·
Model: ClarifEye - 1
·
Philips Medical Systems Nederland B.V.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClarifEye
- Primary DI
- 00884838104570
- Version / Model
- ClarifEye - 1
- Catalog Number
- 002120
- Company Name
- Philips Medical Systems Nederland B.V.
- Labeler DUNS
- 413819707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-12
- Public Version
- 2
- Public Version Date
- 2023-09-26
- Public Version Status
- Update
- Public Device Record Key
- 44bd25c7-1f5f-48b9-b9cb-85db88f9a115
Device Description
Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40885 | Stereotactic system application software | An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838104570 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201743 | 000 |