Catalog Number

-

Brand Name

Bio Compression Systems Bio Cryo Gel Insert - Small

Version/Model Number

CP-S

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

-

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

K961425

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

0446eb7b-d4d0-4737-8203-ec03d28da628

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

November 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-