Identity
- Trade Name
- Premier Edge® Microsurgical Knives FDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- Microsurgical Knife 1.8 mm Slit Knife FDA UDI
- Model / Reference
- PE3818, B-PE3818 FDA UDI
- Description
- Microsurgical Knife 1.8 mm Slit Knife FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845819002926 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, single-use 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Ophthalmic knife, single-use
Premier Edge® Microsurgical Knives by OASIS Medical, Inc. — 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
- OASIS Medical, Inc.
Sources (1)
- FDA UDI 197e3b15-0503-4498-ad4c-7afe9e0c9531 34 fields · synced Jun 9, 2026