Scican Ltd

Address:1440 DON MILLS RD.,TORONTO Ontario,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sterilizer, Steam (FLE) (6) Device, Pasteurization, Hot Water (LDS) (4)

Premarket Exempt

No Yes

Clear

HYDRIM L110W G4 Instrument Washer - 07540196000017 Catalog Number : L110W-D01-G4

Device Description : Automated instrument washer

Device Class : 2

Duns Number: 204137145

Premarket Exempt : Yes

Product Code : LDS

Prescription Use : No

Device Count : 1

HYDRIM L110W G4 Instrument Washer - 07540196000024 Catalog Number : L110W-D01-G4-R

Device Description : Automated instrument washer (Refurbished)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : Yes

Product Code : LDS

Prescription Use : No

Device Count : 1

HYDRIM L110W Instrument Washer - 07540196000031 Catalog Number : L110W-D01-R

Device Description : Automated instrument washer (Refurbished)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : Yes

Product Code : LDS

Prescription Use : No

Device Count : 1

HYDRIM C51W Instrument Washer - 07540196000048 Catalog Number : C51W-D01-R

Device Description : Automated instrument washer (Refurbished)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : Yes

Product Code : LDS

Prescription Use : No

Device Count : 1

STATIM 5000 Cassette Autoclave - 07540196000055 Catalog Number : 01-201103

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

STATIM 5000 Cassette Autoclave - 07540196000062 Catalog Number : 01-201103-L

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber (Loaner)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

STATIM 5000 Cassette Autoclave - 07540196000079 Catalog Number : 01-201103-R

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber (Refurbished)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

STATIM 5000 Cassette Autoclave - 07540196000086 Catalog Number : 01-201104-R

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber (Refurbished)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

STATIM 2000 Cassette Autoclave - 07540196000093 Catalog Number : 01-121101

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

STATIM 2000 Cassette Autoclave - 07540196000109 Catalog Number : 01-121101-L

Device Description : Table-top steam sterilizer with removable cassette sterilization chamber (Loaner)

Device Class : 2

Duns Number: 204137145

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

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