Catalog Number

-

Brand Name

Miracu FCN BI 20Gx90mm

Version/Model Number

W-FTN2090G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172602,K172602,K172602,K172602

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

67f185c1-93e6-48bf-ad30-95a6e13ee55e

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

November 29, 2020

Package DI Number

28809407788353

Quantity per Package

10

Contains DI Package

18809407788356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX