Catalog Number

1003092

Brand Name

CustoMed

Version/Model Number

1

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)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

9f8d8f94-31d2-4826-8461-add4de809d59

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

84895237141167

Quantity per Package

30

Contains DI Package

04895237141161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE