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Premier Edge® Microsurgical Knives

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name
Premier Edge® Microsurgical Knives FDA UDI
Generic Name
Ophthalmic knife, single-use FDA UDI
Device Name
Microsurgical Knife 2.65 mm Slit Knife FDA UDI
Model / Reference
PE3826, B-PE3826 FDA UDI
Description
Microsurgical Knife 2.65 mm Slit Knife FDA UDI

Identifiers

Primary DI / UDI-DI
00845819001820 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
Sterilization Method
Radiation Sterilization FDA UDI

Category: Ophthalmic knife, single-use

Premier Edge Microsurgical Knives are high-quality, precision hand-held instruments designed for precise incisions in the eye and surrounding tissues during ophthalmic surgery. These microsurgical knives feature a sharp, single-edged cutting blade at the distal tip, which can be tailored to specific surgical requirements.

Similar devices

Also classified as Ophthalmic knife, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OASIS Medical, Inc.

Sources (1)

  • FDA UDI a7758089-8ab0-4158-9a3d-3f0fef471a6e 34 fields · synced Jul 9, 2026