EMCYTE CORP.

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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

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (2) Platelet and plasma separator for bone graft handling (ORG) (2)

Premarket Exempt

Clear

PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System - 00855306003695 Catalog Number : GS60-SP

Device Class : 2

Duns Number: 021599728

Premarket Exempt : No

Product Code : ORG

Prescription Use : No

Device Count : 1

PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating System - 00855306003701 Catalog Number : GS120-SP

Device Class : 2

Duns Number: 021599728

Premarket Exempt : No

Product Code : ORG

Prescription Use : No

Device Count : 1

PureSpin PRP Platelet Concentrating System 60mL - 00855306003718 Catalog Number : PS60-PURE

Device Class : 1

Duns Number: 021599728

Premarket Exempt : No

Product Code : JQC

Prescription Use : No

Device Count : 1

PureBMC-30mL GenesisCS Component Concentrating System - 00855306003725 Catalog Number : BC30-PURE

Device Class : 1

Duns Number: 021599728

Premarket Exempt : No

Product Code : JQC

Prescription Use : No

Device Count : 1

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