Catalog Number

DMR190705

Brand Name

GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER

Version/Model Number

DMR190705

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

ae112686-fb02-4c98-a33a-cdf7b0156076

Public Version Date

June 13, 2019

Public Version Number

1

DI Record Publish Date

June 05, 2019

Package DI Number

50884908143756

Quantity per Package

4

Contains DI Package

30884908143752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box