HAMILTON THORNE, INC.

Address:100 CUMMINGS CENTER-SUITE 465E,Beverly,MA,01915,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

Microtools, Assisted Reproduction (Pipettes), Exempt (PUC) (2) Counter, Cell, Automated (Particle Counter) (GKL) (1)

Premarket Exempt

No Yes

Clear

Brilliant Biopsy Micropipette - 00858604006658 Catalog Number :

Device Description : Micropipette, Biopsy, 15µm, Spiked, 0.55mm

Device Class : 2

Duns Number: 152161337

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 1

Brilliant Biopsy Micropipette - 00858604006665 Catalog Number :

Device Description : Micropipette, Biopsy, 28µm, Flat/Blunt, 0.55mm

Device Class : 2

Duns Number: 152161337

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 1

CEROS - 00858604006719 Catalog Number :

Device Description : A modular computerized optical analyzer used for evaluation of sperm samples. It A modular computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.

Device Class : 2

Duns Number: 152161337

Premarket Exempt : No

Product Code : GKL

Prescription Use : No

Device Count : 1

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