1. Vivit International Inc

Address:2nd Floor, Balmoral Hall,Hastings Christ Church,BB

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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

Gown, Examination (FME) (5) Non-Surgical Isolation Gown (OEA) (4) Gown, Isolation, Surgical (FYC) (1)

Premarket Exempt

No Yes

Clear

VIVIT - 10810084210328 Catalog Number :

Device Description : Overhead SMS Gown, Thumbloops with elastic cuffs, Yellow, XL

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 10

VIVIT - 10810084210335 Catalog Number :

Device Description : Overhead Poly-Coated Gown, Thumbloop With Elastic Cuff, Yellow, Universal

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 10

VIVIT - 10810084210342 Catalog Number :

Device Description : Overhead Poly-Coated Gown, Thumbloop With Elastic Cuff, Yellow, XL

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 10

VIVIT - 10810084210359 Catalog Number :

Device Description : Overhead Film Gown, Thumbloops, Blue, Universal

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 15

VIVIT - 10810084210366 Catalog Number :

Device Description : Overhead Film Gown, Thumbloops, Blue, XL

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 15

VIVIT - 10810084210373 Catalog Number :

Device Description : Overhead AAMI 1 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, Universal

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

VIVIT - 10810084210380 Catalog Number :

Device Description : Overhead AAMI 1 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, XL

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

VIVIT - 10810084210397 Catalog Number :

Device Description : Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, Universal

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

VIVIT - 10810084210403 Catalog Number :

Device Description : Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, XL

Device Class :

Duns Number: 815240958

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

VIVIT - 10810084210410 Catalog Number :

Device Description : Overhead AAMI 3 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, Universal

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FYC

Prescription Use : No

Device Count : 10

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