Kolplast C I

Address:Estrada Municipal Benedito De Souza,Itupeva Sao Paulo,BR

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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

Speculum, Vaginal, Nonmetal (HIB) (2) Lamp, Surgical (FTD) (1) Spatula, Cervical, Cytological (HHT) (1)

Premarket Exempt

No Yes

Clear

KOLPLAST - 07898027903519 Catalog Number :

Device Description : Disposable Vaginal Speculum

Device Class : 2

Duns Number: 903963889

Premarket Exempt : No

Product Code : HIB

Prescription Use : No

Device Count : 1

KOLPLAST - 07898027903526 Catalog Number :

Device Description : LED light source for vaginal speculum. Provides illumination during pelvic exami

Device Class : 2

Duns Number: 903963889

Premarket Exempt : No

Product Code : HIB

Prescription Use : No

Device Count : 1

KOLPLAST - 07898027903601 Catalog Number :

Device Description : Wireless LED light source for vaginal speculum. Provides illumination during pel

Device Class : 2

Duns Number: 903963889

Premarket Exempt : Yes

Product Code : FTD

Prescription Use : No

Device Count : 1

KOLPLAST - 07898027905902 Catalog Number :

Device Description : "Cervical Sample Collection Kit, intended for collection of cytological specimen

Device Class : 2

Duns Number: 903963889

Premarket Exempt : No

Product Code : HHT

Prescription Use : No

Device Count : 1

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