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PENTAX Medical

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX Medical FDA UDI
Generic Name
Endoscope fluid protection cap FDA UDI
Device Name
PENTAX Medical Scanning Unit Connector Soaking Cap OE-U4 FDA UDI
Model / Reference
OE-U4 FDA UDI
Description
PENTAX Medical Scanning Unit Connector Soaking Cap OE-U4 FDA UDI

Identifiers

Primary DI / UDI-DI
04961333222223 FDA UDI
510(k) Number
K183516 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Endoscope fluid protection cap FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Endoscope fluid protection cap

PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope fluid protection cap.

Cleared under the same submission

K183516 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI 391dca89-c4ac-4382-b56d-c9f545109d2e 34 fields · synced Jun 6, 2026