Catalog Number

SC1010

Brand Name

TruCath

Version/Model Number

SC1010

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

K142767,K142767,K142767

Product Code

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

d6b65080-e86b-40da-8ae7-688773e38c60

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

10851809002798

Quantity per Package

30

Contains DI Package

00851809002791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box