Catalog Number

-

Brand Name

COROLENE®

Version/Model Number

20S10AE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052701,K052701

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Public Device Record Key

a2ad0f28-4b12-4219-a401-fe5b4ce887d2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 09, 2020

Package DI Number

13661522033132

Quantity per Package

36

Contains DI Package

03661522033135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-