Visitec® EdgeAhead®

FDA UDI

Class I (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name: Visitec® EdgeAhead® FDA UDI
Generic Name: Ophthalmic knife, reusable FDA UDI
Device Name: KNIFE 3.5MM 40DEG PHACO SLIT (5/SP) FDA UDI
Model / Reference: 581121 FDA UDI
Description: KNIFE 3.5MM 40DEG PHACO SLIT (5/SP) FDA UDI

Identifiers

Catalog Number: 581121 FDA UDI
Primary DI / UDI-DI: 30886158100219 FDA UDI
FDA Product Code: HNN FDA UDI
GMDN Term: Ophthalmic knife, 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

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic knife, reusable

Visitec® EdgeAhead® by Beaver-Visitec International, 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: Beaver-Visitec International, Inc.

Sources (1)

FDA UDI 776f40cf-5e01-4522-bc7b-317cc362879e 36 fields · synced May 30, 2026