Catalog Number

H5302

Brand Name

HI-FI

Version/Model Number

IPN000919

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

5e82850d-6f7a-4b56-9ffd-67657cd20dca

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

14026704605221

Quantity per Package

12

Contains DI Package

34026704605225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box