Catalog Number

TFT-55M

Brand Name

CROSSFT

Version/Model Number

TFT-55M

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

Yes

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

HWX

Product Code Name

TAP, BONE

Public Device Record Key

aaa0ef4c-2ff9-480e-b525-04f1d9c31e3a

Public Version Date

August 29, 2022

Public Version Number

2

DI Record Publish Date

January 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-