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Endo-Gator

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
ENDO-GATOR FDA UDI
Generic Name
Surgical fluid/gas irrigator FDA UDI
Device Name
ENDO-GATOR IRRIGATION PUMP FDA UDI
Model / Reference
EGP-100P FDA UDI
Description
ENDO-GATOR IRRIGATION PUMP FDA UDI

Identifiers

Primary DI / UDI-DI
04961333243037 FDA UDI
510(k) Number
K060962 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
Surgical fluid/gas irrigator 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: Surgical fluid/gas irrigator

Endo-Gator by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical fluid/gas irrigator.

Cleared under the same submission

K060962 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 8f78daeb-49e6-4ace-a8be-1b3d55b95f50 34 fields · synced May 30, 2026