FDA.reportPublic FDA data

VENTRALIGHT

Primary DI
00801741130991
Brand
VENTRALIGHT
Company
Davol Inc.
Model
5990015
Catalog number
5990015
Device description
"Ventralight ST Mesh with Echo 2 Positioning System, 6"" (15 cm), Circle"
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric
GCJLaparoscope, general & plastic surgery
ORQMesh, surgical, deployer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
ORQMesh, Surgical, DeployerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741130991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741130991008017411309918017411309910801741130991

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mesh laparoscopic delivery/positioning deviceA sterile, hand-held manual surgical instrument intended to facilitate delivery and/or positioning of surgical mesh for implantation during laparoscopic surgery to repair an abdominal hernia/fascial defect. It consists of a handle with mechanical features used to deploy the mesh, and a distal section for mounting the mesh (e.g., collapsible frame or hollow tube) which is inserted through a laparoscopic port for positioning for subsequent fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags#

DUNS number
001191048
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741233279GalaFLEX 3DRFR3D02BDFR3D02BD2026-04-30
10801741233521GalaFLEX 3DSH3D02BDSH3D02BD2026-04-30
10801741234368GalaFLEX 3DSH3D04BDSH3D04BD2026-04-30
10801741234382GalaFLEX 3DSH3D06BDSH3D06BD2026-04-30
10801741234412GalaFLEX 3DRFR3D04BDFR3D04BD2026-04-30
10801741234436GalaFLEX 3DRFR3D06BDFR3D06BD2026-04-30
00801741074318OPTIFIX011312601131262015-04-16
00801741074325OPTIFIX011312701131272015-04-16
00801741233265GalaFLEX 3DRFR3D01BDFR3D01BD2026-04-30
00801741233494GalaFLEX 3DSH3D01BDSH3D01BD2026-04-30
00801741234354GalaFLEX 3DSH3D03BDSH3D03BD2026-04-30
00801741234378GalaFLEX 3DSH3D05BDSH3D05BD2026-04-30
00801741234392GalaFLEX 3DSH3D07BDSH3D07BD2026-04-30
00801741234408GalaFLEX 3DRFR3D03BDFR3D03BD2026-04-30
00801741234422GalaFLEX 3DRFR3D05BDFR3D05BD2026-04-30
00801741074431ONFLEX011541101154112015-07-17
00801741074424ONFLEX011541001154102015-07-17
00801741010507Avitene101034010103402014-09-12
00801741065323SIMPULSE006731000673102015-12-23
00801741065439SURETRANS859500085950002015-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
09421906017052Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-29
09421905067157Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-14
09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01