Catalog Number

STATURO25

Brand Name

StatLock Urological

Version/Model Number

STATURO25

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

NNX

Product Code Name

DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Public Device Record Key

d50ac2ca-aab8-4d04-95ef-c6c1716cc7d6

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Package DI Number

10801741215909

Quantity per Package

20

Contains DI Package

00801741215902

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA