Exxcel Soft ePTFE Vascular Graft - Exxcel Soft ePTFE SW 5/10 - MAQUET CARDIOVASCULAR LLC

Duns Number:022348156

Device Description: Exxcel Soft ePTFE SW 5/10

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More Product Details

Catalog Number

M002004810150

Brand Name

Exxcel Soft ePTFE Vascular Graft

Version/Model Number

M002004810150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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"

Yes

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

K962433

Product Code Details

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Device Record Status

Public Device Record Key

39f818ea-69fc-4dd9-b040-7580b399157b

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAQUET CARDIOVASCULAR LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 184