Catalog Number

12.1000

Brand Name

Modpod

Version/Model Number

12.1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2019

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

K150695,K150695

Product Code

ITH

Product Code Name

Equipment, Traction, Powered

Public Device Record Key

d01f5ea8-a60f-49c7-a33a-195ca1d48268

Public Version Date

August 30, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

10853096004158

Quantity per Package

1

Contains DI Package

00853096004151

Package Discontinue Date

June 30, 2019

Package Status

Not in Commercial Distribution

Package Type

shipper box