Procell Surgical (us) Inc.

Address:780 Dedham St,Canton,MA,02021,US

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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

Apparatus, Autotransfusion (CAC) (1)

Premarket Exempt

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ProCell Surgical Sponge-Blood Recovery Unit - B890SBRU011 Catalog Number : SBRU-01

Device Description : ProCell™ facilitates the extraction of blood from surgical sponges as a prelimin ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary stepin the process of cell- salvage/intra-operative autotransfusion (IAT).ProCell™ functions as a blood collection device only and does not filter or otherwiseprocess the blood recovered. As an accessory to IAT, it is used in conjunction withstandard cell-salvage equipment which must process the blood retrieved from ProCell™prior to re-infusion into the patient.Designed for ease-of-use directly on the surgical instrument table, the disposableProCell™ can be used repeatedly during a surgical case and provides an alternative toother sponge-blood recovery methods including hand-wringing.

Device Class : 2

Duns Number: 117681877

Premarket Exempt : No

Product Code : CAC

Prescription Use : Yes

Device Count : 1

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