Catalog Number

96346

Brand Name

SIS MEDICAL 40atm Inflation Device

Version/Model Number

QL® 2540

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

KOE

Product Code Name

Dilator, Urethral

Public Device Record Key

2938ca91-adb6-46c4-801c-2894e4c71a45

Public Version Date

September 03, 2020

Public Version Number

2

DI Record Publish Date

May 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-