PREASSEMBLED SURGICAL WASH SET

GUDID 38033178105188

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system set
Primary Device ID38033178105188
NIH Device Record Keyf7d1a01f-2715-4421-a14a-af7ad63a3f51
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREASSEMBLED SURGICAL WASH SET
Version Model NumberCOD.740E - 175 ML BOWL
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033178105187 [Primary]
GS138033178105188 [Package]
Contains: 08033178105187
Package: BOX [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-08
Device Publish Date2015-07-15

On-Brand Devices [PREASSEMBLED SURGICAL WASH SET]

38033178105249WS-225E
38033178105232WS-175E
38033178105225WS-125E
38033178105218WS-55E
38033178105201COD.740E - 225 ML BOWL
38033178105188COD.740E - 175 ML BOWL
38033178105164COD.740E - 125 ML BOWL
38033178105140COD.740E - 55 ML BOWL
38033178105089WS-55C
38033178105072WS-225C
38033178105058WS-125C
38033178105041COD.740C-55 ML BOWL
38033178105034COD.740C-225 ML BOWL
38033178105027COD.740C-175 ML BOWL
38033178105010COD.740C-125 ML BOWL

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