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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
Endoscopic irrigation/distension bottle FDA UDI
Device Name
PENTAX Water Bottle Assembly FDA UDI
Model / Reference
OS-H5 FDA UDI
Description
PENTAX Water Bottle Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
04961333251049 FDA UDI
FDA Product Code
PEA FDA UDI
GMDN Term
Endoscopic irrigation/distension bottle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic irrigation/distension bottle

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

Similar devices

Also classified as Endoscopic irrigation/distension bottle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI e712b351-e265-413d-9525-4a13dca0881f 33 fields · synced Jun 8, 2026