Catalog Number

CID-25-15

Brand Name

Sphere™ Inflation Device

Version/Model Number

QL 2515

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

1fcc1439-728a-4c3d-b14e-d665a47b4da2

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

10827002462837

Quantity per Package

1

Contains DI Package

00827002462830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-