Quest Projects B.V.

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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

Laparoscope, General & Plastic Surgery (GCJ) (3) Confocal Optical Imaging (OWN) (2)

Premarket Exempt

Clear

Quest Spectrum Platform - 08719324487009 Catalog Number : ART-SYS-0019

Device Class : 2

Duns Number: 386614502

Premarket Exempt : No

Product Code : GCJ, OWN

Prescription Use : Yes

Device Count : 1

Quest Laparoscope - 08719324487016 Catalog Number : ART-LAP-0006

Device Class : 2

Duns Number: 386614502

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Quest Laparoscope - 08719324487023 Catalog Number : ART-LAP-0007

Device Class : 2

Duns Number: 386614502

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Quest Spectrum Kit for open surgery - 08719324487030 Catalog Number :

Device Description : kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004

Device Class : 2

Duns Number: 386614502

Premarket Exempt : No

Product Code : OWN

Prescription Use : Yes

Device Count : 1

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