FDA.reportPublic FDA data

VENTRALIGHT

Primary DI
00801741131059
Brand
VENTRALIGHT
Company
Davol Inc.
Model
5992533
Catalog number
5992533
Device description
"Ventralight ST Mesh with Echo 2 Positioning System, 10"" x 13"" (25 x 33 cm), Ellipse"
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
00801741131059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741131059008017411310598017411310590801741131059

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA sterile, flat, or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications, and excludes devices designed specifically for diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Width25Centimeter

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
00801741010149SIMPULSE006760000676002015-12-23
00801741010309ULTREX006771000677102015-12-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300169TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300176TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300183TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300190TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300206TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300213TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300220TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300237TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300275TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22