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I-Series Washers

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
I-Series Washers FDA UDI
Generic Name
Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
Device Name
I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold and fil rinse water connection, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Electric, 208V FDA UDI
Model / Reference
I5-S-E FDA UDI
Description
I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold and fil rinse water connection, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Electric, 208V FDA UDI

Identifiers

Catalog Number
I5-S-E FDA UDI
Primary DI / UDI-DI
10841736100612 FDA UDI
FDA Product Code
MEC FDA UDI
GMDN Term
Surgical instrument washer/disinfector (chemical/thermal) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6992 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument washer/disinfector (chemical/thermal)

I-Series Washers by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument washer/disinfector (chemical/thermal).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 377ce578-02d5-4150-9634-274d148b8e47 35 fields · synced Jun 1, 2026