Catalog Number

CID-40-15

Brand Name

Sphere™ Inflation Device

Version/Model Number

QL4015

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

5319cb2a-69e6-4957-a96e-b2ed61f131cc

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

10827002496740

Quantity per Package

1

Contains DI Package

00827002496743

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-