Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- Kelman McPherson Angled Castroviejo Handle Forceps 10.0mm (110 mm overall) Stainless Steel FDA UDI
- Model / Reference
- ECF-10SS FDA UDI
- Description
- Kelman McPherson Angled Castroviejo Handle Forceps 10.0mm (110 mm overall) Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346ECF10SS0 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
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Also classified as Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable.
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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 b2471304-4b0c-4739-a1d2-d3bb22a6a091 34 fields · synced May 31, 2026