Catalog Number

-

Brand Name

Miracu FCL FORTE FIX 18Gx100mm

Version/Model Number

3FX18101802GA

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

44cd841c-0609-4cac-8d4f-c340bb101f51

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

28800145503413

Quantity per Package

10

Contains DI Package

18800145503416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX