FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix ICON Cart System
DI: 00857253006057
·
Model: PCI 40-1000
·
Phoenix Clinical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix ICON Cart System
- Primary DI
- 00857253006057
- Version / Model
- PCI 40-1000
- Company Name
- Phoenix Clinical
- Labeler DUNS
- 949114925
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-30
- Public Version
- 1
- Public Version Date
- 2021-12-08
- Public Version Status
- New
- Public Device Record Key
- a438073a-b7bd-4f0a-b8f0-cbdf619eea16
Device Description
The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
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
- 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 |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 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 | 00857253006057 | GS1 |
Customer Contacts
- Phone
- 925-485-1100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170527 | 000 |