FDA UDI
In Commercial Distribution
🇺🇸 United States
Ophthalmic Slit Lamp Microscope
DI: 06973211070381
·
Model: LS-1B
·
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Ophthalmic Slit Lamp Microscope
- Primary DI
- 06973211070381
- Version / Model
- LS-1B
- 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
- 2020-07-02
- Public Version
- 3
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 0a5b05d9-b89e-4f4b-b167-30763d4997c8
Device Description
It is an AC-powered slit lamp Biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 26973211070378 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 06973211070381 | GS1 | ||||
| Package | 26973211070385 | GS1 | 4 | In Commercial Distribution | ||
| Package | 26973211070392 | GS1 | 6 | In Commercial Distribution | ||
| Package | 26973211070408 | GS1 | 8 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182306 | 000 |