Catalog Number

13530008

Brand Name

DeRoyal

Version/Model Number

13530008

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

FSD

Product Code Name

BINDER, ABDOMINAL

Public Device Record Key

4698deb4-0a7f-4dc1-a1f4-7fe69d0f6557

Public Version Date

July 28, 2021

Public Version Number

1

DI Record Publish Date

July 20, 2021

Package DI Number

50749756295401

Quantity per Package

36

Contains DI Package

00749756295406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case