Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- .12 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .20 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .30 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .50 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel FDA UDI
- Model / Reference
- ECF-04SS FDA UDI
- Description
- .12 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .20 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .30 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .50 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346ECF04SS0 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
No
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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- 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 60438722-c94d-4a39-8265-11f081024b4f 34 fields · synced May 31, 2026