Catalog Number

-

Brand Name

BGEcare Sterile Lap Sponge

Version/Model Number

LS041818040540S

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

b93083c6-fa76-4e7a-8a42-9d01c0493db7

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2021

Package DI Number

06972403300602

Quantity per Package

40

Contains DI Package

06972403300596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box