Catalog Number

68-567W-MC

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

df25ef29-1549-44e4-a357-063dd574b2f1

Public Version Date

July 17, 2020

Public Version Number

2

DI Record Publish Date

July 06, 2020

Package DI Number

84895237141082

Quantity per Package

25

Contains DI Package

74895237141085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE