CEEK WOMEN'S HEALTH

Address:2175 NW Raleigh Street,Portland,OR,97210,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

Light, Examination, Medical, Battery Powered (KYT) (2) Speculum, Vaginal, Nonmetal (HIB) (2)

Premarket Exempt

Yes

Clear

Nella VuSleeve - 00860000270403 Catalog Number :

Device Description : Single-Use Retraction Sheath

Device Class :

Duns Number: 116951931

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

Nella VuLight - 00860000270410 Catalog Number :

Device Description : Single Use LED Illuminator

Device Class : 1

Duns Number: 116951931

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : Yes

Device Count : 50

Nella NuSpec - 00860000270427 Catalog Number :

Device Description : Reusable Vaginal Speculum

Device Class : 2

Duns Number: 116951931

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

Nella VuLight - 10860000270448 Catalog Number :

Device Description : Single Use LED Illuminator

Device Class :

Duns Number: 116951931

Premarket Exempt : Yes

Product Code : KYT

Prescription Use : Yes

Device Count : 5

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