FDA.reportPublic FDA data

PROCELL SURGICAL INC.

Matched from indexed company URL: ProCell Surgical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30169945513016994551PROCELL SURGICAL INC.1N2026-01-01780 Dedham St Suite 700 Canton MA US 02021

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B890SBRU011ProCell Surgical Sponge-Blood Recovery Unit - 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.617-849-7900customerservice@procellsi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2708851727315229K193361ProCell Surgical Sponge-Blood Recovery UnitCAC2020-06-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAC12020-06-01

PMN#

GUDID#

ProCell Surgical Sponge-Blood Recovery Unit - 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.

Procell Surgical (us) Inc.

2020-12-01