FDA UDI
In Commercial Distribution
🇺🇸 United States
IS-5500
DI: 00850053428616
·
Model: 23060-11-000-GV
·
TOPCON HEALTHCARE INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IS-5500
- Primary DI
- 00850053428616
- Version / Model
- 23060-11-000-GV
- Company Name
- TOPCON HEALTHCARE INC
- Labeler DUNS
- 053547238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-28
- Public Version
- 2
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- af6af5f2-e362-41ed-8552-4fd0e53e02ac
Device Description
IS-5500 OPHTHALMIC STAND GRAND VISION 110V; AC-Powered Ophthalmic Instrument Stand
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 |
|---|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | 886.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36255 | Static ophthalmic equipment stand, manually-adjusted | A device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It may have a manually-operated height adjustment function (e.g., a hydraulic foot pump or adjustable threaded column) enabling the user to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850053428616 | GS1 |