VENTRALIGHT ST Mesh with ECHO 2 Positioning System 5991823

GUDID 00801741131028

Ventralight™ ST Mesh with Echo 2™ Positioning System 18cm x 23cm / 7“ x 9“ Ellipse

Davol Inc.

Abdominal hernia surgical mesh, composite-polymer
Primary Device ID00801741131028
NIH Device Record Keye18d326f-b859-49ca-98d2-1f1a5dfc0ad6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTRALIGHT ST Mesh with ECHO 2 Positioning System
Version Model Number5991823
Catalog Number5991823
Company DUNS001191048
Company NameDavol Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com

Device Dimensions

Length23 Centimeter
Length23 Centimeter
Length23 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter
Width18 Centimeter
Length23 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741131028 [Primary]

FDA Product Code

ORQMesh, surgical, deployer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-25

On-Brand Devices [VENTRALIGHT ST Mesh with ECHO 2 Positioning System]

00801741131066Ventralight™ ST Mesh with Echo 2™ Positioning System 30cm x 35cm / 12“ x 14“ Ellipse
00801741131042Ventralight™ ST Mesh with Echo 2™ Positioning System 20cm x 25cm / 8“ x 10“ Ellipse
00801741131028Ventralight™ ST Mesh with Echo 2™ Positioning System 18cm x 23cm / 7“ x 9“ Ellipse
00801741131011Ventralight™ ST Mesh with Echo 2™ Positioning System 15cm x 25cm / 6“ x 10“ Oval
00801741131004Ventralight™ ST Mesh with Echo 2™ Positioning System 15cm x 20cm / 6“ x 8“ Ellipse
00801741130984Ventralight ST Mesh with ECHO 2 Positioning System 10 cm x 15 cm (4" x 6") Ellipse
00801741130977Ventralight ST Mesh with ECHO 2 Positioning System 11 cm (4.5)" Circle

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.