Catalog Number

944

Brand Name

PKIT, ANDREWS FRAME

Version/Model Number

944-1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMQ

Product Code Name

Restraint, Protective

Public Device Record Key

3c214ad1-aba8-4577-907d-a94151a76e06

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 05, 2019

Package DI Number

10842430110839

Quantity per Package

3

Contains DI Package

00842430110832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case