Catalog Number

-

Brand Name

MoldCARE Cushion Trapezoid

Version/Model Number

P10107-646

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2022

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

K081218,K081218

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

979a0a90-3c50-45f8-8974-5c8fa5eb0a52

Public Version Date

February 14, 2022

Public Version Number

8

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-