Catalog Number

1U-0640-135-02

Brand Name

PROTEUS

Version/Model Number

1U-0640-135-02

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133043

Product Code

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Public Device Record Key

387ba754-c73d-4123-89df-4e0cea5c296c

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

August 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-