Ventralight™ ST Mesh with Echo 2™ Positioning System - Ventralight™ ST Mesh with Echo 2™ Positioning - Davol Inc.

Duns Number:001191048

Device Description: Ventralight™ ST Mesh with Echo 2™ Positioning System20cm / 8“ circle

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More Product Details

Catalog Number

5990020

Brand Name

Ventralight™ ST Mesh with Echo 2™ Positioning System

Version/Model Number

5990020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Device Record Status

Public Device Record Key

f87d4d14-bd11-4c50-9f15-51d0e99d26ab

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAVOL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 348
3 A medical device with high risk that requires premarket approval 18