Identity
- Trade Name
- OSSEOUS Rosen Inserter FDA UDI
- Generic Name
- Tympanostomy tube inserter, single-use FDA UDI
- Device Name
- "Rosen Inserter are used to hook out wax or foreign bodies from the ear canal. " FDA UDI
- Model / Reference
- EI0959 FDA UDI
- Description
- "Rosen Inserter are used to hook out wax or foreign bodies from the ear canal. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904461000321 FDA UDI
- FDA Product Code
- JYG FDA UDI
- GMDN Term
- Tympanostomy tube inserter, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 145 Millimeter FDA UDIOuter Diameter — 0.50 Millimeter FDA UDI
Category: Tympanostomy tube inserter, single-use
OSSEOUS Rosen Inserter by Eon Meditech Private Limited — 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
- Eon Meditech Private Limited
Sources (1)
- FDA UDI b8c1458e-23ee-4f37-9a49-6044e6a058d9 35 fields · synced Jun 8, 2026