Catalog Number

MTACLSHIM

Brand Name

AccuForm™ Shim

Version/Model Number

MTACLSHIM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180021,K180021

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Public Device Record Key

2df1533c-2673-45ac-8f81-1c0f30a814ed

Public Version Date

August 11, 2022

Public Version Number

2

DI Record Publish Date

May 16, 2021

Package DI Number

10841439113582

Quantity per Package

10

Contains DI Package

00841439113585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-