Catalog Number

-

Brand Name

ELASTY FCL FORTE2 19Gx100mm

Version/Model Number

3PS119101603G

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

292e3e17-9cf8-443d-8d58-a72f534b664f

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 24, 2019

Package DI Number

38809407786844

Quantity per Package

300

Contains DI Package

28809407786847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON BOX