FDA UDI
In Commercial Distribution
🇺🇸 United States
LUMENIS
DI: 08056098470012
·
Model: SL 990 3X LUMENIS
·
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LUMENIS
- Primary DI
- 08056098470012
- Version / Model
- SL 990 3X LUMENIS
- Catalog Number
- 100226A30
- Company Name
- COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
- Labeler DUNS
- 432448470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 6
- Public Version Date
- 2023-12-25
- Public Version Status
- Update
- Public Device Record Key
- 6c80bf4b-989b-47cc-bb8b-c07933712a32
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 |
|---|---|---|---|---|---|---|
| Package | 8056098470609 | GS1 | CARTON BOX | 1 | In Commercial Distribution | |
| Primary | 08056098470012 | GS1 | ||||
| Package | 8056098470593 | GS1 | CARTON BOX | 1 | In Commercial Distribution |