Catalog Number

-

Brand Name

FlexiCoil™

Version/Model Number

FC-0.9-2-20-GG-18-20

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100267

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

d9803bd4-886a-4805-b2d0-134d27813a77

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-