Catalog Number

510700

Brand Name

GentleCath

Version/Model Number

510700

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

K213283,K213283,K213283

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

16cd1711-6eae-4b75-999e-9fdd6243c042

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

00768455198467

Quantity per Package

10

Contains DI Package

00768455198450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton