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 1.75MM 60DEG BEV UP CRESCENT (5/SP) FDA UDI
Model / Reference: 581137 FDA UDI
Description: KNIFE 1.75MM 60DEG BEV UP CRESCENT (5/SP) FDA UDI

Identifiers

Catalog Number: 581137 FDA UDI
Primary DI / UDI-DI: 30886158100332 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

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic knife, reusable

A comprehensive 2-3 paragraph SEO description written in clear, natural language. This medical device is a hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically made of high-grade stainless steel and employs diamond blades for micro-incision cataract surgery.

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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 45bc1277-6030-44bc-9b23-5cc17871beed 36 fields · synced Jul 8, 2026