FDA.reportPublic FDA data

Kerri DiPietro

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066972993006697299Kerri DiPietro1N2026-01-0111 Cabot Blvd Mansfield MA US 02048
30138865233013886523Kerri DiPietro1N2026-01-0111 Cabot Blvd Mansfield MA US 02048

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2108081428097792K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
2108081088532226K991413CODMAN ETHISORB DURA PATCHGXQ2000-03-13
446411408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
2108081839003887K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
2108081505347487K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
446411214703546K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
2108081185205031K944222CODMAN-MEDOS VALVE SHUNT SYSTEMJXG1995-07-28
2108082038978903K914479MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCERGWM1994-03-07
446411845845260K864380LUTEX HEADLIGHT SYSTEMSFST1986-11-19
2108081902114912K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG2023-12-19
2108081368725883K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterJXG2024-01-17
446411393210386K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM2024-02-04
446411824474489K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2023-07-11
2108081051015535K223330Certas Plus Programmable ValvesJXG2023-02-01
2108081457802808K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG2022-10-14
446411746230866K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-08-22
446411942806843K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-07-15
446411845126550K210993CereLink ICP MonitorGWM2021-04-30
446411670523884K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2019-04-01
446411755722249K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2018-12-07
2108081878737732K182265CodMan Certas Plus Programmable ValveJXG2018-11-20
446411216066706K181902Codman Certas Plus Electronic Tool KitJXG2018-10-25
2108081693815661K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitGWM2017-11-08
2108081580077502K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG2017-10-16
2108081074127371K163106CODMAN Integrated Bipolar Cord and Tubing SetGEI2016-12-01
2108081687590741K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar ForcepsGEI2016-10-26
2108082036327615K162437Codman EDS3 CSF External Drainage SystemJXG2016-10-28
446412016034898K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2016-10-14
2108081871858685K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitGWM2016-08-19
2108081146067237K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesGWM2016-01-22
2108081529386886K152152Codman Certas Plus Programmable ValveJXG2015-10-27
2108081422354150K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitJXG2015-02-19
446411892720264K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2014-11-06
2108081602032618K140722INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELSJXG2015-01-06
446411230482150K131184INTEGRA LICOX PTO2 MONITORGWM2013-08-30
2108081014898985K122118HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEMJXG2012-08-03
446411578588807K121573INTEGRA CAMINO ICP MONITORGWM2012-09-10
446411939106339K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTERGWM2012-07-20
2108082025305733K110751CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETERJXG2011-05-09
446411419483138K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMFSR2011-05-11
2108081699518506K102961HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODMJXG2011-02-18
2108081475649943K102589CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETERJXG2011-01-14
2108081196189534K093968OSV II LOW FLOW LOW PRO VALVEJXG2010-01-22
2108081889763245K092395OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEMJXG2009-11-19
2108081731672422K091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPHCH2009-09-08
2108081533398381K090348CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SETJXG2009-03-04
2108081653267825K081773OSV IIJXG2008-11-06
446411795204646K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMLFL2008-08-13
2108081843934010K061876CODMAN VPV SYSTEM, MODEL 82-3192JXG2006-10-16
2108081338155504K061568CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738JXG2006-09-29
2108081612851940K053350MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMSJXG2006-01-19
2108081523342892K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITGWM2006-05-10
2108081245298057K053107CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARDJXG2006-01-19
2108081575710423K042192LOW FLOW OSV II HYDROCEPHALUS VALVEJXG2004-09-02
2108082070471398K041296MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SIJXG2004-06-10
2108081344293041K040235LICOX PMO BRAIN MONITORING SYSTEMGWM2004-04-20
446411344293041K040235LICOX PMO BRAIN MONITORING SYSTEMGWM2004-04-20
2108081188378649K032817EXTERNAL DRAINAGE SETJXG2003-10-06
2108081327420314K031123CODMAN BACTISEAL BARIUM STRIPED CATHETERSHCA2003-05-14
446411767932990K031086CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1GWM2003-05-14
446411277946391K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3LFL2002-09-13
2108081153552524K021653CODMAN BACTISEAL EVD CATHETER SETJXG2002-07-29
2108081510826916K020667CODMAN HAKIM SHUNT SYSTEMSJXG2002-03-28
2108081456510645K003564HAKIM PROGRAMMER AND TRANSMITTERJXG2000-12-20
2108081297645215K003322CODMAN BACTISEAL CATHETERSHCA2001-10-01
446411595200704K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPEGWM2000-11-24
2108081595200704K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPEGWM2000-11-24
2108081029764925
446411301371333
2108081316585240
446411469997238
446411538946523
2108081706277950
446411716109379
446411870506591
446411892012339

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG322024-01-17
GWM172024-02-04
LFL102023-07-11
GEI22016-12-01
HCA22003-05-14
FSR12011-05-11
HCH12009-09-08
GXQ12000-03-13
FST11986-11-19