← Back to catalogue

SYSTEM 1 endo

FDA UDI

Class II (US FDA UDI)

by Corporation Steris Canada

Identity

Trade Name
SYSTEM 1 endo FDA UDI
Generic Name
Liquid sterilant sterilizer FDA UDI
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices. FDA UDI
Model / Reference
1 endo FDA UDI
Description
SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices. FDA UDI

Identifiers

Catalog Number
P6900 FDA UDI
Primary DI / UDI-DI
00724995170554 FDA UDI
510(k) Number
K182827 FDA UDI
K190104 FDA UDI
K191343 FDA UDI
K192929 FDA UDI
K210737 FDA UDI
K211607 FDA UDI
K222615 FDA UDI
K230582 FDA UDI
K232914 FDA UDI
FDA Product Code
MED FDA UDI
GMDN Term
Liquid sterilant sterilizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6885 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Liquid sterilant sterilizer

SYSTEM 1 endo by Corporation Steris Canada — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Liquid sterilant sterilizer.

Cleared under the same submission

K182827 also covers:

K190104 also covers:

K191343 also covers:

K192929 also covers:

K210737 also covers:

K211607 also covers:

K222615 also covers:

K230582 also covers:

K232914 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Corporation Steris Canada

Sources (1)

  • FDA UDI 32d17518-607e-4f35-950d-9adccacb0fde 36 fields · synced Jun 8, 2026