Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Self-retaining ear speculum FDA UDI
- Device Name
- ZOELLNER EAR SPECULUM BLACK 7.5X8.5MM FDA UDI
- Model / Reference
- OF173 FDA UDI
- Description
- ZOELLNER EAR SPECULUM BLACK 7.5X8.5MM FDA UDI
Identifiers
- Catalog Number
- OF173 FDA UDI
- Primary DI / UDI-DI
- 04038653176069 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Self-retaining ear speculum FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Commercial Distribution
- Not 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
Aesculap by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Aesculap, Inc.
Sources (1)
- FDA UDI 116f2052-2c38-4e9e-be44-1e7e6d029cd5 36 fields · synced Jun 1, 2026