Catalog Number

4061800

Brand Name

Dila-Cath Nelaton 40cm CH18

Version/Model Number

40618

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FBX

Product Code Name

SOUND, URETHRAL, METAL OR PLASTIC

Public Device Record Key

c201b2a7-5819-4b7d-be44-95e3931caa96

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Package DI Number

07392532088087

Quantity per Package

2

Contains DI Package

07392532088094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Transport Packaging