Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- Colibri .12 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .20 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .30 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .50 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel FDA UDI
- Model / Reference
- ECF-14SS FDA UDI
- Description
- Colibri .12 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .20 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .30 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel Colibri .50 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346ECF14SS0 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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- 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
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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 e2033119-625d-4cf1-a226-a8abe6c8367d 34 fields · synced Jun 6, 2026