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Water Container (cap And Tube)

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
WATER CONTAINER (CAP AND TUBE) FDA UDI
Generic Name
Endoscopic irrigation/distension bottle FDA UDI
Device Name
GX9538 WATER CONT. W/CLIP & O RING FDA UDI
Model / Reference
MA-995 FDA UDI
Description
GX9538 WATER CONT. W/CLIP & O RING FDA UDI

Identifiers

Primary DI / UDI-DI
04953170025563 FDA UDI
FDA Product Code
GCJ 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic irrigation/distension bottle

Water Container (cap And Tube) by Olympus Medical Systems 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

Sources (1)

  • FDA UDI fff971ae-ec77-447a-ad15-74073c66ed00 34 fields · synced May 30, 2026