Catalog Number

-

Brand Name

epic edge

Version/Model Number

N2627

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

344c4983-e757-4ef3-b9f3-ed139632a363

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 13, 2018

Package DI Number

10855019008038

Quantity per Package

12

Contains DI Package

00855019008031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box