Catalog Number

-

Brand Name

Guide Wire for Edi catheter 6Fr/ 49 and 50 cm

Version/Model Number

6671270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

992cc53f-d44f-44c3-8147-6616607aaa4a

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 20, 2019

Package DI Number

17325710006549

Quantity per Package

5

Contains DI Package

07325710006542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-