Identity
- Trade Name
- ri-scope® F.O. nasal speculum LED 3.5 V, FDA UDI
- Generic Name
- ENT diagnostic set FDA UDI
- Device Name
- The nasal speculum is produced for illumination and therefore examination of the inside of the nose. FDA UDI
- Model / Reference
- 10575-301 FDA UDI
- Description
- The nasal speculum is produced for illumination and therefore examination of the inside of the nose. FDA UDI
Identifiers
- Catalog Number
- 10575-301 FDA UDI
- Primary DI / UDI-DI
- 04045396147157 FDA UDI
- 510(k) Number
- K950913 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- ENT diagnostic set 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: ENT diagnostic set
ri-scope® F.O. nasal speculum 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 a501b743-6b02-4d5c-8c31-9320b354349a 35 fields · synced May 30, 2026