Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-702

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

403b53d9-2e0e-45b6-b109-f55d2d4e8706

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 21, 2016

Package DI Number

00815849022027

Quantity per Package

20

Contains DI Package

00815849022010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-