Catalog Number

41035-01

Brand Name

Cragg-McNamara

Version/Model Number

41035-01

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940634

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

faa9638c-cb3a-4339-9cfa-93b78f512c8e

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

October 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-