Identity
- Trade Name
- RZ Medizintechnik GmbH FDA UDI
- Generic Name
- Ear speculum, reusable FDA UDI
- Device Name
- Rosen Aural Speculum 38mm, 4.0mm bore unslotted, round end, black finish FDA UDI
- Model / Reference
- 410-016-002 FDA UDI
- Description
- Rosen Aural Speculum 38mm, 4.0mm bore unslotted, round end, black finish FDA UDI
Identifiers
- Catalog Number
- 410-016-002 FDA UDI
- Primary DI / UDI-DI
- 04049197470476 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Ear speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ear speculum, reusable
RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — 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
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI 70bbf5d1-d2a1-476c-b1c3-6dbc0f22e985 35 fields · synced May 30, 2026