Catalog Number

-

Brand Name

RELI

Version/Model Number

PT1002-SI

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

b8005828-c118-4cd5-b10f-bcf584a75582

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

April 15, 2016

Package DI Number

20386120006325

Quantity per Package

30

Contains DI Package

10386120006328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case