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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 patient protection cap, single-use FDA UDI
Device Name
PENTAX Medical Single Use, Non-Sterile Distal End Cap OE-A62 FDA UDI
Model / Reference
OE-A62 FDA UDI
Description
PENTAX Medical Single Use, Non-Sterile Distal End Cap OE-A62 FDA UDI

Identifiers

Primary DI / UDI-DI
14961333232960 FDA UDI
510(k) Number
K163614 FDA UDI
FDA Product Code
FDT FDA UDI
GMDN Term
Endoscope patient protection cap, single-use 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

No

FDA UDI

Category: Endoscope patient protection cap, single-use

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

Similar devices

Also classified as Endoscope patient protection cap, single-use.

Cleared under the same submission

K163614 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 5ac6f544-c14f-410e-bda4-16cac335463b 34 fields · synced Jun 8, 2026