STATIM 5000 G4 Cassette Autoclave

FDA UDI

Class II (US FDA UDI)

by Scican GmbH

Identity

Trade Name: STATIM 5000 G4 Cassette Autoclave FDA UDI
Generic Name: Steam sterilizer FDA UDI
Device Name: Table-top steam sterilizer with removable cassette sterilization chamber (Loaner) FDA UDI
Model / Reference: G4-201103-L FDA UDI
Description: Table-top steam sterilizer with removable cassette sterilization chamber (Loaner) FDA UDI

Identifiers

Catalog Number: G4-201103-L FDA UDI
Primary DI / UDI-DI: 07540196000437 FDA UDI
FDA Product Code: FLE FDA UDI
GMDN Term: Steam sterilizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Steam sterilizer

STATIM 5000 G4 Cassette Autoclave by Scican GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Scican GmbH

Sources (1)

FDA UDI d810fdc3-284e-4d54-ae61-2aa696d65afc 35 fields · synced May 30, 2026