THERMO SHANDON LIMITED

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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

Dispensers, Paraffin (IDW) (5) Slide Stainer, Automated (KPA) (4) Device For Sealing Microsections (KIM) (1)

Premarket Exempt

Yes

Clear

Thermo Fisher - 05051663001915 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001922 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001939 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663001946 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002219 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KIM

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002288 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002295 Catalog Number :

Device Description : 100-120V 50/60 Hz

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002301 Catalog Number :

Device Description : 220-240V 50/60 Hz (CHINA ONLY)

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002417 Catalog Number :

Device Description : 220-240V 50/60HZ

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002424 Catalog Number :

Device Description : 100-120V 50/60HZ

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

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