Catalog Number

XFA008115

Brand Name

SUBFIX

Version/Model Number

XFA008115

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HWT

Product Code Name

TEMPLATE

Public Device Record Key

1f3b5c4e-f246-4cab-977f-4f3304a82294

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

January 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-