Catalog Number

US1724

Brand Name

Syneture

Version/Model Number

US1724

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OVN

Product Code Name

Suture kit

Public Device Record Key

dae57d5e-a56a-4fda-bd26-e8ca5cbd1601

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 20, 2017

Package DI Number

20884521707105

Quantity per Package

6

Contains DI Package

10884521707108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK