Catalog Number

-

Brand Name

BGEcare Sterile Lap Sponge

Version/Model Number

LS04181804051004S

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

29f0fea9-a002-4626-b861-719003d68bbf

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

06972403300626

Quantity per Package

10

Contains DI Package

06972403300619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box