FDA.reportPublic FDA data

VENTRALIGHT ST with ECHO 2 Positioning System

Primary DI
00801741131059
Brand
VENTRALIGHT ST with ECHO 2 Positioning System
Company
Davol Inc.
Model
5992533
Catalog number
5992533
Device description
Ventralight™ ST Mesh with Echo 2™ Positioning System 25cm x 33cm / 10“ x 13“ 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741233678GalaFLEXGP0103BDGP0103BD2025-09-25
00801741233685GalaFLEXGP0206BDGP0206BD2025-09-25
00801741233692GalaFLEXGP0208BDGP0208BD2025-09-25
00801741233708GalaFLEXGP0408BDGP0408BD2025-09-25
00801741233715GalaFLEXGP0608BDGP0608BD2025-09-25
00801741233722GalaFLEX LITEGFLT0207BDGFLT0207BD2025-09-25
00801741233739GalaFLEX LITEGFLT0515BDGFLT0515BD2025-09-25
00801741233746GalaFLEX LITEGFLT0520BDGFLT0520BD2025-09-25
00801741233753GalaFLEX LITEGFLT0013BDGFLT0013BD2025-09-25
00801741233760GalaFLEX LITEGFLT1020BDGFLT1020BD2025-09-25
00801741233777GalaFLEX LITEGFLT0015BDGFLT0015BD2025-09-25
00801741233784GalaFLEX LITEGFLT0017BDGFLT0017BD2025-09-25
00801741233791GalaFLEX LITEGFLT1520BDGFLT1520BD2025-09-25
00801741233814GalaFLEX LITEGFLT0019BDGFLT0019BD2025-09-25
00801741233821GalaFLEX LITEGFLT0022BDGFLT0022BD2025-09-25
00801741233838GalaFLEX LITEGFLT0025BDGFLT0025BD2025-09-25
00801741233852GalaFLEX LITEGFLT2025BDGFLT2025BD2025-09-25
00801741234019GalaFLEX LITEGFLT2530BDGFLT2530BD2025-09-25
00801741226519Phasix123000712300072025-02-24
00801741226533Phasix123000912300092025-02-24

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Primary DI, Brand, Company table
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