Catalog Number

-

Brand Name

Pristina Paddle

Version/Model Number

SLD FX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162268

Product Code

FMQ

Product Code Name

Restraint, protective

Public Device Record Key

e94fcc74-cff0-4125-8565-d03d24f0f546

Public Version Date

October 28, 2022

Public Version Number

5

DI Record Publish Date

January 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-