Stephens Instruments

FDA UDI

Class U (US FDA UDI)

by Krishna Imports Inc

Identity

Trade Name: Stephens Instruments FDA UDI
Generic Name: Lacrimal punctum plug FDA UDI
Device Name: Vera90 Synthetic Extended Inserts - 0.4mm FDA UDI
Model / Reference: ESP-1004 FDA UDI
Description: Vera90 Synthetic Extended Inserts - 0.4mm FDA UDI

Identifiers

Catalog Number: ESP-1004 FDA UDI
Primary DI / UDI-DI: 00810061910947 FDA UDI
510(k) Number: K020882 FDA UDI
FDA Product Code: LZU FDA UDI
GMDN Term: Lacrimal punctum plug 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Lacrimal punctum plug

Stephens Instruments by Krishna Imports Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lacrimal punctum plug.

SuperFlex — Katena Products, Inc. · U
Diamatrix — Diamatrix · U
Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
Comfortear Lacrisolve 180 Absorbable Punctum Plug — RIVERPOINT MEDICAL LLC · U
Diamatrix — Diamatrix · U
SOFT PLUG® Silicone Punctum Plug — OASIS Medical, Inc. · U
Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
TearSaver® - 0.7 mm — FCI S A S FCI 20 22 · U

Cleared under the same submission

K020882 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 U	Pending data

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Manufacturer

Manufacturer: Krishna Imports Inc

Sources (1)

FDA UDI 8784968c-7a0e-4c08-b06e-4d479f768f39 37 fields · synced Jun 6, 2026