Catalog Number

16180L001

Brand Name

iFIX

Version/Model Number

Patch 15

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)

-

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

a1ee7a99-a757-40fc-85f3-c2e72a8e8fb4

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

March 31, 2019

Package DI Number

49010279000037

Quantity per Package

4

Contains DI Package

29010279000033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box