Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- Utrata Capsulorhexis Triangular Grasping Tips w/ Platform Curved Shanks Round Handle Forceps (110 mm overall) Titanium FDA UDI
- Model / Reference
- ERF-29C FDA UDI
- Description
- Utrata Capsulorhexis Triangular Grasping Tips w/ Platform Curved Shanks Round Handle Forceps (110 mm overall) Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346ERF29C0 FDA UDI
- FDA Product Code
- HNR FDA UDI
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, 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 soft-tissue manipulation forceps, tweezers-like, 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 soft-tissue manipulation forceps, tweezers-like, reusable.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- GILL IRIS FORCEPS CURVED — Katena Products, Inc. · Class I
- Kedar Nath Das Obstetrical Forceps, 38cm — Rhein Enterprises (Pvt) Ltd · 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 |
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Manufacturer
- Manufacturer
- Epsilon Eye Care Private Limited
Sources (1)
- FDA UDI 81d59255-2979-4ad4-a988-19bcf99412c7 34 fields · synced Jun 1, 2026