Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- Iris Spatula Curved Probe (128 mm overall) Titanium FDA UDI
- Model / Reference
- EP-01C FDA UDI
- Description
- Iris Spatula Curved Probe (128 mm overall) Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346EP01C0 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Ophthalmic surgical probe, 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical probe, reusable
Epsilon USA by Epsilon Eye Care Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, reusable.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Titanium Nucleus Splitter — KATALYST SURGICAL, LLC · Class I
- Scleral Depressors — AURORA SURGICAL, LLC · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epsilon Eye Care Private Limited
Sources (1)
- FDA UDI 2dce7b8c-7fa9-41aa-8a6f-bfb85832eeed 34 fields · synced Jun 8, 2026