Catalog Number

SD-4080

Brand Name

Medline Industries, Inc.

Version/Model Number

SD-4080

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"

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

f4ded2a3-9397-46c0-b0fa-dbc9bb9baf22

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-