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

Duns Number:001191048

Device Description: Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse

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More Product Details

Catalog Number

1211015

Brand Name

Phasix™ ST Mesh with Echo 2™ Positioning System

Version/Model Number

1211015

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

1b643976-3b43-46e3-b02f-38869be3b921

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

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