FDA UDI
In Commercial Distribution
🇺🇸 United States
MARCO
DI: 04560323648472
·
Model: MARCO ULTRA M3
·
TAKAGI SEIKO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MARCO
- Primary DI
- 04560323648472
- Version / Model
- MARCO ULTRA M3
- Company Name
- TAKAGI SEIKO CO.,LTD.
- Labeler DUNS
- 690907167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-25
- Public Version
- 5
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 52c4df83-ea99-405a-a6f5-d2a091add54b
Device Description
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 04560323648472 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162636 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal