Catalog Number

1-230

Brand Name

DeRoyal

Version/Model Number

1-230

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

5d586e14-603b-4aea-9df1-0c6e266710bb

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

50749756264964

Quantity per Package

50

Contains DI Package

00749756264969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case