Catalog Number

MTP701

Brand Name

TIELLE® MAX

Version/Model Number

MTP701

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

929f68ee-138a-4859-93f9-56eee4c73407

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2019

Package DI Number

25051978001307

Quantity per Package

10

Contains DI Package

15051978001300

Package Discontinue Date

February 28, 2021

Package Status

Not in Commercial Distribution

Package Type

-