THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Address:275 Aiken Rd,ASHEVILLE,NC,28804,US

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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

Accessory, Assisted Reproduction (MQG) (4) Indicator, Biological Sterilization Process (FRC) (3)

Premarket Exempt

No Yes

Clear

Thermo Scientific Forma - 10815773020196 Catalog Number : 7458

Device Description : Controlled Rate Freezer

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020202 Catalog Number : 7459

Device Description : Controlled Rate Freezer

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020219 Catalog Number : 7475

Device Description : Controlled Rate Freezer

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Thermo Scientific Forma - 10815773020226 Catalog Number : 7476

Device Description : Controlled Rate Freezer

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

BT Sure - 10815773020240 Catalog Number : AY759X3

Device Description : BT Sure - Steam - Biological Indicators, 100 count

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

BT Sure - 10815773020257 Catalog Number : AY759X8

Device Description : BT Sure - Steam - Biological Indicator, 100 count

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

BT Sure - 10815773020264 Catalog Number : AY759X1

Device Description : BT Sure - Steam - Biological Indicators, 5 count

Device Class : 2

Duns Number: 791530061

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

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