Catalog Number

BM-HX11-CC

Brand Name

Bathmate

Version/Model Number

Hydroxtreme 11 CC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LKY

Product Code Name

Device, External Penile Rigidity

Public Device Record Key

11884869-ba8d-4a3a-8a2b-860aef54281d

Public Version Date

April 05, 2018

Public Version Number

1

DI Record Publish Date

March 05, 2018

Package DI Number

05060140209232

Quantity per Package

10

Contains DI Package

05060140209225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box