Catalog Number

RT-1922

Brand Name

Aquaplast RT™

Version/Model Number

RT-1922

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

Yes

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

K935067,K935067

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

fa2e1aac-8397-4d2e-8d29-9b6f99ff9542

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-