Catalog Number

128733

Brand Name

Medline Industries, Inc.

Version/Model Number

128733

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

KGS

Product Code Name

RETENTION DEVICE, SUTURE

Public Device Record Key

6cb105de-22fc-4f2e-9df4-da311530e579

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

July 28, 2019

Package DI Number

40193489754699

Quantity per Package

13

Contains DI Package

10193489754698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE