Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1213643

FEI Number

1213643

Entity Name

DAVOL INC., SUB. C.R. BARD, INC.

City/State/Country

Warwick, RI, US

Establishment Address

100 Crossings Blvd, Warwick, RI 02886, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100229

PMA Number

N/A

All Registered Proprietary Names

Composix ONFLEX Phasix Ventrio Ventralex Phasix 3DMax SorbaFix PermaFix Ventralight OptiFix GalaFLEX LITE Phasix Tridyne Bard PerFix OptiFix Avitene Ventralight Echo 2 GalaFLEX 3DR XenMatrix ONFLEX Avitene Ultrafoam PerFix XenMatrix GalaFLEX Phasix Echo 2 Hydro-Surg Hydro-Surg Phasix ARISTA FlexiTip HemaDERM Kugel Bard Mesh BARD Bard Mesh Pre-Shaped CapSure Ventrio

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2015-03-20
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2016-11-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2011-06-29
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	2013-03-01
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2013-03-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-09-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2011-06-29
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-12-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-07-16
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-09-20
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-02-20
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2025-02-20
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2025-02-20
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2024-02-05
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	2007-02-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-05-01
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2008-01-30
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
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-09-20
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
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2008-05-02
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-02-01
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
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-09-20
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-09
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
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2015-01-14
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2015-01-14
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2015-01-14
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2015-01-14
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	2025-06-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-06-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-05-11

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
1424526	BARD BRACHYTHERAPY, INC	CAROL STREAM, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01
K103263	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY	2010-11-22
K130717	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RELOAD	2013-04-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1213643. Last updated year: 2026. Please use registration number 1213643 when referencing this establishment in official correspondence.