Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-857

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

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

6714704b-e293-44ff-9803-488d2d6d5683

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

November 21, 2016

Package DI Number

00815849022225

Quantity per Package

10

Contains DI Package

00815849022218

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-