FDA.reportPublic FDA data

VENTRALIGHT

Primary DI
00801741130984
Brand
VENTRALIGHT
Company
Davol Inc.
Model
5991015
Catalog number
5991015
Device description
"Ventralight ST Mesh with Echo 2 Positioning System, 4"" x 6"" (10 x 15 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
00801741130984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741130984008017411309848017411309840801741130984

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
Length15Centimeter
Width10Centimeter

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@cbard.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
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18