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HE Inc.

FDA UDI

Class II (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name
HE Inc. FDA UDI
Generic Name
Ophthalmic sponge FDA UDI
Device Name
HE INC. PVA EYE SPEAR W/DK BLUE HANDLE (200/SP) FDA UDI
Model / Reference
23275-500 FDA UDI
Description
HE INC. PVA EYE SPEAR W/DK BLUE HANDLE (200/SP) FDA UDI

Identifiers

Catalog Number
23275-500 FDA UDI
Primary DI / UDI-DI
30886158013762 FDA UDI
FDA Product Code
HOZ FDA UDI
GMDN Term
Ophthalmic sponge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4790 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Ophthalmic sponge

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

Similar devices

Also classified as Ophthalmic sponge.

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 808fc771-90c0-435d-a2a0-57775cb2f96a 36 fields · synced May 31, 2026