O'well

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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

Lancet, Blood (FMK) (4)

Premarket Exempt

No Yes

Clear

owell - 00860167002565 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002572 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002589 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002596 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

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