Catalog Number

-

Brand Name

Miracu FCL FORTE FIX 19Gx70mm

Version/Model Number

3FX19071601GA

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

72bada88-f5d1-4932-8a6f-8e8fb9def181

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

28800145503420

Quantity per Package

10

Contains DI Package

18800145503423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX