Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Liberman "K" Wire Eye Speculum Screw Type Temporal Bend (82mm Overall) Titanium FDA UDI
- Model / Reference
- E1-202 FDA UDI
- Description
- Liberman "K" Wire Eye Speculum Screw Type Temporal Bend (82mm Overall) Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346E12020 FDA UDI
- FDA Product Code
- HNC FDA UDI
- GMDN Term
- Eyelid speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eyelid speculum, reusable
Epsilon USA by Epsilon Eye Care Private Limited — 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
- Epsilon Eye Care Private Limited
Sources (1)
- FDA UDI 6c8aab60-90e8-41e2-83b5-79bdcf0f2595 34 fields · synced Jun 1, 2026