FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocular Surface Analyzer
DI: 06973211070763
·
Model: DA-1
·
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ocular Surface Analyzer
- Primary DI
- 06973211070763
- Version / Model
- DA-1
- Company Name
- CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
- Labeler DUNS
- 545824560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-15
- Public Version
- 1
- Public Version Date
- 2021-06-23
- Public Version Status
- New
- Public Device Record Key
- 91c5cdad-a71d-4f0f-b205-238964b53160
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| PUE | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62593 | Meibomian gland camera/ophthalmic interferometer | A mains electricity (AC-powered) multi-purpose optical device intended for: 1) infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands; 2) measurement of the tear film lipid layer using white light image/video capture interferometry; and 3) image capture of the external ocular anatomy. It includes patient head/chin supports, an IR source(s), appropriate cameras, controls and software intended to allow analysis of the images/video and interferometry; it may include an eyelid everter to assist imaging of the meibomian glands. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973211070763 | GS1 |