BARD SHANNON LIMITED

FDA Device Registration & Listing · Humacao, PR, US · Registration 3005636544

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005636544
FEI Number
3005636544
Entity Name
BARD SHANNON LIMITED
City/State/Country
Humacao, PR, US
Establishment Address
San Geronimo Industrial Park, Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo, Humacao, PR 00791, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
C. R. Bard, Inc. (Owner Number: 2212754)
Owner / Operator Contact Address
1 Becton Drive, Franklin Lakes, NJ 07417, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ventrio Ventralight GalaFLEX 3DR Vacora Vacuum Assisted Biopsy Sys SorbaFix PermaFix UltraClip II US Tissue Marker Marker (Ribbon) UltraClip Dual Trigger Tissue Ventralight Echo 2 3DMax XenMatrix ONFLEX UltraClip II Tissue Marker ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS Composix Ventralex UltraCor Twirl Breast Tissue Marker 3DMax Bard Button Gastrostomy Tube Kugel Alyte Y-Mesh Graft Loc-Strap Bard Male External Catheter (OTC) Bard Infection Control Urinary Needleless Sample Port Control Fit Urine Collection Container - bag/urinary drainage unit Bard Deluxe Dispoz-A-Bag Drainage Bag (Leg Bag) Urinary Drainage Unit(urinary leg Urotrack Plus (Model 220) Bard Leg Bag Holder w/ accessories) Bed Bag SureStep Foley Tray System Add-A-Foley Catheter (for Canada) Bard Foley Catheterization Tray Uro-Prep Tray (for Canada) SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada) Bard Standard Latex Free Foley Tray without Catheter (for Canada) Bard Male External Latex Disposable Catheter Bardia Foley Catheter Insertion w/o Catheter with Lubricant in SureStep Intermittent Catheter Tray Bard® Universal Catheterization Tray Bardia Urethral Catheter Tray 5cc Balloon w/o Catheter w/o Catheter Foley Catheter Insertion Tray for 30cc Balloon w/o Catheter Bard Foley Catheterization Tray PerFix Bard Ventralight Echo PS GalaFLEX Sepramesh Bard Mesh BARD Bard Mesh Pre-Shaped UltraClip Dual Trigger Breast Tissue Marker (Wing and Coil) UltraClip II MR Tissue Marker GalaFLEX LITE UltraCor Twirl Breast Tissue Marker 3DMax ONFLEX Ventrio Phasix PTFE Felt Bard PTFE Felt Pledget Low Porosity PTFE Felt PTFE Felt (Thick) Bard PTFE Braided Tape Bard PTFE Thick Felt Pledget OptiFix XenMatrix CapSure Phasix UltraClip II Tissue Marker Wing and UltraClip II Tissue Marker Coil OptiFix DuaLok Breast Lesion Localization Wire Ghiatas Beaded Breast Localization Wire XenMatrix Phasix Echo 2 PerFix Align Urethral Support System Phasix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-07-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-07-10
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2010-05-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2010-12-21
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2024-09-20
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2009-01-08
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2011-06-29
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2008-11-11
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-11-11
ORQ Mesh, Surgical, Deployer General, Plastic Surgery Class 2 878.3300 2017-08-17
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2017-08-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-08-17
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-09-17
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2017-02-16
PIJ Collagen Surgical Mesh Containing Drugs General, Plastic Surgery Class 2 878.3300 2017-02-16
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2017-02-16
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-04-15
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-11-11
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2008-11-11
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2014-03-28
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2008-01-09
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-06-29
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2025-03-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2020-07-20
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2007-02-27
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2008-01-09
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2011-04-13
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2007-02-27
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2007-02-27
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-04-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-08-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-08-09
OQL Mesh, Surgical, Deployment Balloon General, Plastic Surgery Class 2 878.3300 2013-08-09
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2024-09-20
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2008-01-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-06-16
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2009-12-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-11-11
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2024-09-20
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2016-06-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-09-17
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-03-20
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-06-29
OWT Mesh, Surgical, Absorbable, Abdominal Hernia General, Plastic Surgery Class 2 878.3300 2019-06-12
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2019-06-12
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-06-12
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2019-06-12
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2007-10-22
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2010-04-13
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2019-07-16
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2014-05-16
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2014-05-16
OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery Class 2 878.3300 2014-05-16
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2016-06-01
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2016-11-15
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2008-11-11
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-11-11
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2015-03-16
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2003-10-31
PIJ Collagen Surgical Mesh Containing Drugs General, Plastic Surgery Class 2 878.3300 2015-08-04
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2015-08-04
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2015-08-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-12-19
ORQ Mesh, Surgical, Deployer General, Plastic Surgery Class 2 878.3300 2018-12-19
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2018-12-19
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-12-19
OWT Mesh, Surgical, Absorbable, Abdominal Hernia General, Plastic Surgery Class 2 878.3300 2018-12-19
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2010-02-01
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2007-12-10
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-13
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2018-07-13
OWZ Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction General, Plastic Surgery Class 2 878.3300 2018-07-13
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2018-07-13
OWT Mesh, Surgical, Absorbable, Abdominal Hernia General, Plastic Surgery Class 2 878.3300 2018-07-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1725056 MEDIVANCE, INC. LOUISVILLE, CO, US
3006513822 Lutonix, Inc. Tempe, AZ, US
1223089 DAVOL INC. WOBURN, MA, US
3002504068 Bard European Distribution Center NV Olen Antwerpen, BE
1213643 DAVOL INC., SUB. C.R. BARD, INC. Warwick, RI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005636544. Last updated year: 2026. Please use registration number 3005636544 when referencing this establishment in official correspondence.
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