FDA UDI
In Commercial Distribution
🇺🇸 United States
Slit Lamp HS-7500
DI: 08800019600077
·
Model: HS-7500(LED)
·
Huvitz Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Slit Lamp HS-7500
- Primary DI
- 08800019600077
- Version / Model
- HS-7500(LED)
- Catalog Number
- HS-7500(LED)
- Company Name
- Huvitz Co., Ltd.
- Labeler DUNS
- 688154202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 3
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- ac5f76a2-d059-416a-a774-8426c8f29be7
Device Description
" -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)" -. The SLIT LAMP is intended for use in eye examination of the anterior eye segments, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect 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
- 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 |
|---|---|---|---|---|
| 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 | 08800019600077 | GS1 |
Customer Contacts
- Phone
- +82314289100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093639 | 000 |