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Visitec®

FDA UDI

Class I (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name
Visitec® FDA UDI
Generic Name
Lacrimal tube insertion hook/pusher FDA UDI
Device Name
Lacrimal Intubation with Retrieval Device .60mm x 11cm (23G x 4 1/4in) 3 FDA UDI
Model / Reference
585013 FDA UDI
Description
Lacrimal Intubation with Retrieval Device .60mm x 11cm (23G x 4 1/4in) 3 FDA UDI

Identifiers

Catalog Number
585013 FDA UDI
Primary DI / UDI-DI
30886158101247 FDA UDI
510(k) Number
K831901 FDA UDI
FDA Product Code
HNL FDA UDI
GMDN Term
Lacrimal tube insertion hook/pusher 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Lacrimal intubation setLacrimal tube insertion hook/pusher

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

Similar devices

Also classified as Lacrimal tube insertion hook/pusher.

Cleared under the same submission

K831901 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beaver-Visitec International, Inc.

Sources (1)

  • FDA UDI d1d85fe5-a111-4af3-a1b5-e9728cb2900c 36 fields · synced May 30, 2026