Identity
- Trade Name
- SYSTEM TABLE FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer. FDA UDI
- Model / Reference
- ST-5100 FDA UDI
- Description
- The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100806 FDA UDI
- FDA Product Code
- HRJ FDA UDI
- GMDN Term
- Instrument table FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4855 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument table
System Table by Nidek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI fe9ae642-4741-4061-8585-a9804b114d10 34 fields · synced May 29, 2026