Catalog Number

RNL-12-038J/C

Brand Name

ReSolve®

Version/Model Number

00884450645574

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

-

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

904c154c-f3ff-44e7-962f-19f6c5147ee2

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

10884450645571

Quantity per Package

5

Contains DI Package

00884450645574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-