Identity
- Trade Name
- ri-scope® F.O. tongue blade holder LED 3.5 V FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- The blade holder described in these Operating Instructions is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. FDA UDI
- Model / Reference
- 10574 FDA UDI
- Description
- The blade holder described in these Operating Instructions is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. FDA UDI
Identifiers
- Catalog Number
- 10574 FDA UDI
- Primary DI / UDI-DI
- 04045396141322 FDA UDI
- 510(k) Number
- K950913 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixed examination/treatment room light
ri-scope® F.O. tongue blade holder LED 3.5 V by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950913 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI d7f83c54-d58e-4cc9-9130-a84c0fd097a6 35 fields · synced May 30, 2026