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 15°, 3mm Restricted Depth Knife FDA UDI
Model / Reference: PE3015-3, B-PE3015-3 FDA UDI
Description: Microsurgical Knife 15°, 3mm Restricted Depth Knife FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819002223 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 3.0 Millimeter FDA UDI
Angle — 15 degree FDA UDI

Category: Ophthalmic knife, single-use

Premier Edge Microsurgical Knives are high-quality, single-use ophthalmic surgical instruments designed for precise incisions in the eye and surrounding tissues. These microsurgical knives feature a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end, suitable for various applications such as cataract surgery or retinal detachment procedures.

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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 f9573570-bd97-499c-a7b6-ef94dc2f7b1a 35 fields · synced Jul 8, 2026