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LacriCATH

FDA UDI

Class U (US FDA UDI)

by Quest Medical Inc

Identity

Trade Name
LacriCATH FDA UDI
Generic Name
Lacrimal intubation set FDA UDI
Device Name
LacriCATH Model DCP213-BIT contains two lacrimal duct catheters, one AQL1015 Inflation device, and one K12-01811 stopcock. FDA UDI
Model / Reference
DCP213-BIT FDA UDI
Description
LacriCATH Model DCP213-BIT contains two lacrimal duct catheters, one AQL1015 Inflation device, and one K12-01811 stopcock. FDA UDI

Identifiers

Primary DI / UDI-DI
20634624438228 FDA UDI
510(k) Number
K113867 FDA UDI
FDA Product Code
OKS FDA UDI
GMDN Term
Lacrimal intubation set FDA UDI

Classification

Device Class
U 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

Yes

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 set

LacriCATH by Quest Medical Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lacrimal intubation set.

Cleared under the same submission

K113867 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest Medical Inc

Sources (1)

  • FDA UDI f4565773-8f83-421c-8d18-a7b3db1651b6 34 fields · synced May 30, 2026