Catalog Number

65-TS-FlatTamp

Brand Name

Fortilink-TS IBF System

Version/Model Number

65-TS-FlatTamp

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

HXG

Product Code Name

TAMP

Public Device Record Key

2f8b6a8f-15e0-47fb-8e9e-0b6e9dc28040

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

October 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-