Catalog Number

-

Brand Name

CoreTech

Version/Model Number

SUP2101

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILI

Product Code Name

Sling, Arm

Public Device Record Key

045b547f-532f-4c2c-846c-f3286d9e894f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2022

Package DI Number

10850041211005

Quantity per Package

12

Contains DI Package

00850041211008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case