Catalog Number

-

Brand Name

Diacor Overlay

Version/Model Number

ZXL-TGE-11

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

-

Product Code

KXJ

Product Code Name

Table, Radiologic

Public Device Record Key

5ccd93ea-9496-4f54-bbd4-0b4e5159c78b

Public Version Date

February 07, 2020

Public Version Number

3

DI Record Publish Date

January 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-