Celling Biosciences

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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

Bone Marrow Collection/Transfusion Kit (LWE) (4) Syringe, Piston (FMF) (4) Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (3) Platelet And Plasma Separator For Bone Graft Handling (ORG) (2) Kit, Surgical Instrument, Disposable (KDD) (1)

Premarket Exempt

No Yes

Clear

SpineSmith Fusionary Graft Delivery System - 00817771027361 Catalog Number : 0851-1070

Device Description : Small Volume Bone Marrow Aspiration Kit

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : FMF, LWE

Prescription Use : Yes

Device Count : 1

SpineSmith Fusionary Graft Delivery System - 00817771027378 Catalog Number : 0851-3060

Device Description : Blood Draw Kit

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : FMF, LWE

Prescription Use : Yes

Device Count : 1

SpineSmith Fusionary Graft Delivery System - 00817771027385 Catalog Number : 0852-0001

Device Description : Graft Delivery Kit

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : FMF, LWE

Prescription Use : Yes

Device Count : 1

SpineSmith Fusionary Graft Delivery System - 00817771027392 Catalog Number : 0852-0120

Device Description : 120cc: Graft Delivery Kit

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : FMF, LWE

Prescription Use : Yes

Device Count : 1

SpineSmith Fusionary Graft Delivery System - 00817771027408 Catalog Number : 0861-0003

Device Description : Celling Injection Kit

Device Class : 1

Duns Number: 021560394

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Celling ART BMC System - 00817771027446 Catalog Number : 0882-0002

Device Description : ART Counterbalance

Device Class : 1

Duns Number: 021560394

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

Celling ART BMC System - 00817771027477 Catalog Number : 0882-0005

Device Description : ART Counterbalance

Device Class : 1

Duns Number: 021560394

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

Celling ART PRP System - 00817771027491 Catalog Number : 0885-0001

Device Description : ART PRP Device

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Celling ART PRP System - 00817771027507 Catalog Number : 0865-0002

Device Description : ART PRP Plus Device

Device Class : 2

Duns Number: 021560394

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Celling ART BMC System - 00817771027514 Catalog Number : 0866-0001

Device Description : ART BMC Device

Device Class : 1

Duns Number: 021560394

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

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