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Endo Optiks®

FDA UDI

Class II (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name
Endo Optiks® FDA UDI
Generic Name
Rigid optical ophthalmic endoscope FDA UDI
Device Name
23 Gauge High Resoluton Endoscope FDA UDI
Model / Reference
OME230HRA FDA UDI
Description
23 Gauge High Resoluton Endoscope FDA UDI

Identifiers

Primary DI / UDI-DI
30886158016176 FDA UDI
510(k) Number
K910532 FDA UDI
FDA Product Code
HQP FDA UDI
GMDN Term
Rigid optical ophthalmic endoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4115 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rigid optical ophthalmic endoscope

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

Similar devices

Also classified as Rigid optical ophthalmic endoscope.

Cleared under the same submission

K910532 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 6fe0c1a9-1f6f-481d-87c2-eda2dbeb577b 36 fields · synced May 30, 2026