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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
Flexible video gastroscope, reusable FDA UDI
Device Name
PENTAX Medical Video Esophagoscope EE17-J10 FDA UDI
Model / Reference
EE17-J10 FDA UDI
Description
PENTAX Medical Video Esophagoscope EE17-J10 FDA UDI

Identifiers

Primary DI / UDI-DI
04961333251766 FDA UDI
FDA Product Code
EOX FDA UDI
GMDN Term
Flexible video gastroscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4710 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video gastroscope, reusable

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

Similar devices

Also classified as Flexible video gastroscope, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI 3303ada2-ce67-44ba-862a-125c38d7266d 33 fields · synced May 31, 2026