Identity
- Trade Name
- Epsilon USA FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- Sinskey Hook Angled (125 mm overall) Stainless Steel Fine Sinskey Hook Angled .12 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled .18 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled .20 mm Probe (125 mm overall) Stainless Steel FDA UDI
- Model / Reference
- EP-02SS FDA UDI
- Description
- Sinskey Hook Angled (125 mm overall) Stainless Steel Fine Sinskey Hook Angled .12 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled .18 mm Probe (125 mm overall) Stainless Steel Sinskey Hook Angled .20 mm Probe (125 mm overall) Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G346EP02SS0 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
No
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
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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 db3cbff0-1825-48f4-945c-2563d7662bd2 34 fields · synced Jun 8, 2026