Catalog Number

MDS251726LF

Brand Name

Medline

Version/Model Number

MDS251726LF

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Public Device Record Key

e3d76f1f-ebef-4af5-b1e5-3ea8e95b044e

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

March 31, 2021

Package DI Number

40080196921073

Quantity per Package

20

Contains DI Package

10080196921072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE