Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-7101

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

GBA

Product Code Name

Catheter, Balloon Type

Public Device Record Key

6950c8a2-09a9-47bc-b18d-c0a8ffa6ed88

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

November 21, 2016

Package DI Number

00815849022089

Quantity per Package

10

Contains DI Package

00815849022072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-