Catalog Number

MTAPCIN1832

Brand Name

Solstice™ Thermoplastic Frame

Version/Model Number

MTAPCIN1832

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

K182079,K182079

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

2c0014c0-bde8-488a-9d38-e1762b048409

Public Version Date

July 17, 2020

Public Version Number

3

DI Record Publish Date

January 08, 2019

Package DI Number

00841439112564

Quantity per Package

5

Contains DI Package

10841439112561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-