Catalog Number

-

Brand Name

Curble Chair

Version/Model Number

Curble Chair Cover_Grand_Caramel

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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

IQE

Product Code Name

Orthosis, Lumbar

Public Device Record Key

dfc003c7-c885-4f59-bca4-c7b8017fdd0a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-