Catalog Number

NITGW3260ST

Brand Name

Centurion

Version/Model Number

NITGW3260ST

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

937e705e-1db7-4584-af1c-f92306c892c4

Public Version Date

October 15, 2019

Public Version Number

1

DI Record Publish Date

October 07, 2019

Package DI Number

10653160329749

Quantity per Package

10

Contains DI Package

20653160329746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE