Catalog Number

-

Brand Name

NAMIC

Version/Model Number

91400400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K903606,K903606

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

f6fee014-b042-41f7-8f35-f41b2ae6374b

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

H965914004001

Quantity per Package

10

Contains DI Package

H965914004000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX