Catalog Number

-

Brand Name

Sunmark

Version/Model Number

B FMDLS 0130 R02401 SM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 03, 2022

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRL

Product Code Name

Fiber, Medical, Absorbent

Public Device Record Key

3a2aca90-13f0-4163-98bc-80642a380eca

Public Version Date

January 04, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2020

Package DI Number

10010939593334

Quantity per Package

24

Contains DI Package

00010939593337

Package Discontinue Date

January 03, 2022

Package Status

Not in Commercial Distribution

Package Type

Case