Catalog Number

MTAPSSPF

Brand Name

Solstice™ Shoulder Thermoplastic

Version/Model Number

MTAPSSPF

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

daefc567-ce59-4917-8af5-870605124285

Public Version Date

August 11, 2022

Public Version Number

3

DI Record Publish Date

September 13, 2020

Package DI Number

10841439113261

Quantity per Package

5

Contains DI Package

00841439113264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-