Catalog Number

23275-680

Brand Name

V. Mueller

Version/Model Number

23275-680

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)

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

85858669-df5e-4fe2-aa84-6dbcca57a007

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 12, 2018

Package DI Number

70885403067770

Quantity per Package

5

Contains DI Package

10885403067778

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack