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Irrigator/Insufflator

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
IRRIGATOR/INSUFFLATOR FDA UDI
Generic Name
Electrical mains power cable FDA UDI
Device Name
POWER CORD, EGA-500P/EGA-501P FDA UDI
Model / Reference
EGA-7014 FDA UDI
Description
POWER CORD, EGA-500P/EGA-501P FDA UDI

Identifiers

Primary DI / UDI-DI
04961333242979 FDA UDI
510(k) Number
K113310 FDA UDI
FDA Product Code
FCX FDA UDI
GMDN Term
Electrical mains power cable 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrical mains power cable

Irrigator/Insufflator by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical mains power cable.

Cleared under the same submission

K113310 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI fd5a1146-4297-402a-88ec-f9c0404a0a63 34 fields · synced Jun 7, 2026