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Fluid Safe

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Fluid Safe FDA UDI
Generic Name
Hysteroscopic irrigation/insufflation system FDA UDI
Device Name
Fluid Management System, Pump Unit FDA UDI
Model / Reference
0502000001 FDA UDI
Description
Fluid Management System, Pump Unit FDA UDI

Identifiers

Catalog Number
0502-000-001 FDA UDI
Primary DI / UDI-DI
07613327058116 FDA UDI
FDA Product Code
HIG FDA UDI
GMDN Term
Hysteroscopic irrigation/insufflation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1700 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

No

FDA UDI

Category: Hysteroscopic irrigation/insufflation system

Fluid Safe by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hysteroscopic irrigation/insufflation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI d901bf4d-da9c-408a-9374-95c3568fd545 35 fields · synced Jun 1, 2026