SURGIMESH®WN - Non woven, non knitted reinforcement material - ASPIDE MEDICAL

Duns Number:395941714

Device Description: Non woven, non knitted reinforcement material made from polypropylene.

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More Product Details

Catalog Number

T221510

Brand Name

SURGIMESH®WN

Version/Model Number

T221510

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

9abec946-78a3-4d3e-90e1-0ade7397d2fd

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

03700296903791

Quantity per Package

5

Contains DI Package

03700296900721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ASPIDE MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44