Catalog Number

42316403

Brand Name

LoFric® Hydro-Kit™

Version/Model Number

42316

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

EZD

Product Code Name

CATHETER, STRAIGHT

Public Device Record Key

3fab1d4b-8b86-4202-aab6-bda4c83a7f40

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

07392532247637

Quantity per Package

2

Contains DI Package

07392532247620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Transport Packaging