FDA UDI
In Commercial Distribution
🇺🇸 United States
YEASN
DI: 06971922135030
·
Model: YF-100
·
Chongqing Yeasn Science & Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YEASN
- Primary DI
- 06971922135030
- Version / Model
- YF-100
- Company Name
- Chongqing Yeasn Science & Technology Co.,Ltd.
- Labeler DUNS
- 547954649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-27
- Public Version
- 4
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 0b6b094f-33b3-4222-a62e-774e95200c67
Device Description
For eye examination and aid in the diagnosis. Contraindications: none. Target groups of patients: adults, children. Intended users: optometrists in hospital ophthalmology and optical shops. The people who use this product are ophthalmologists in hospitals or clinics, and optometrists in optical shops. To operate this product, they should have relevant knowledge of eye examinations and have the relevant skills to operate the product.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35148 | Ophthalmic examination slit lamp | An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971922135030 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161764 | 000 |