Catalog Number

NL9054

Brand Name

V. Mueller

Version/Model Number

NL9054

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2021

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)

Yes

Over the Counter (OTC)

-

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

dfdec097-2727-43d2-8c1f-31cf3a3470c8

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

20885403128506

Quantity per Package

20

Contains DI Package

70885403128501

Package Discontinue Date

February 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Box