FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RetCam Shuttle
DI: 00899281002120
·
Model: RetCam Shuttle
·
CLARITY MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RetCam Shuttle
- Primary DI
- 00899281002120
- Version / Model
- RetCam Shuttle
- Company Name
- CLARITY MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 808456037
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-19
- Public Version
- 3
- Public Version Date
- 2021-02-09
- Public Version Status
- Update
- Public Device Record Key
- 23c2e7e5-d225-4f82-8012-207f1533c40a
- Distribution End Date
- 2017-08-31
Device Description
The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos 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
- 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 |
|---|---|---|---|---|
| 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 | 00899281002120 | GS1 |
Customer Contacts
- Phone
- 9256213222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 20.7 – 31.3 Inches of Mercury
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 95 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 20.7 – 31.3 Inches of Mercury