FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix Clinical ICON
DI: 00857253006040
·
Model: PJZ
·
Phoenix Clinical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix Clinical ICON
- Primary DI
- 00857253006040
- Version / Model
- PJZ
- Catalog Number
- PCI-40-1000-P
- Company Name
- Phoenix Clinical
- Labeler DUNS
- 949114925
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 334c9581-afa7-4de9-97d6-f66df80ac678
Device Description
The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information.
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 |
|---|---|---|---|---|
| PJZ | Camera, Ophthalmic, General-Use | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10551 | Ophthalmic fundus camera | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857253006040 | GS1 |
Customer Contacts
- Phone
- 925-462-5000
- [email protected]