Catalog Number

Code HEA-50W

Brand Name

SUPRAMID EXTRA

Version/Model Number

Code HEA-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

08842294-ce76-4cc2-84d2-7f22d8dff125

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 11, 2017

Package DI Number

10816848023647

Quantity per Package

12

Contains DI Package

00816848023640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box