Visitec®

FDA UDI

Class I (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name: Visitec® FDA UDI
Generic Name: Lacrimal intubation set FDA UDI
Device Name: DCR Set (Angled) [O'Donoghue] .90mm x 4.5cm (20G x 1 3/4in) FDA UDI
Model / Reference: 585012 FDA UDI
Description: DCR Set (Angled) [O'Donoghue] .90mm x 4.5cm (20G x 1 3/4in) FDA UDI

Identifiers

Catalog Number: 585012 FDA UDI
Primary DI / UDI-DI: 30886158101230 FDA UDI
510(k) Number: K831901 FDA UDI
FDA Product Code: HNL FDA UDI
GMDN Term: Lacrimal intubation set 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Lacrimal intubation set

Visitec® by Beaver-Visitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lacrimal intubation set.

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LACRIJET® 50 — FCI S A S FCI 20 22 · U
Novo Surgical — NOVO SURGICAL, INC. · Class I
Crawford — JEDMED Instrument Company · U
Lacrimal Intubation Set, Crawford Type — QUEST MEDICAL INC · U
Crawford — JEDMED Instrument Company · U

Cleared under the same submission

K831901 also covers:

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 94d54475-416f-4087-8282-04d1673d87eb 36 fields · synced May 31, 2026