Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-515

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

NNI

Product Code Name

Container, Specimen, Non-Sterile

Public Device Record Key

8ec0e0e0-9372-40a4-b5cd-05433f5aa8bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 21, 2016

Package DI Number

00815849020740

Quantity per Package

10

Contains DI Package

00815849020177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-