Catalog Number

TLN2122EN

Brand Name

TIELLE® NON ADHESIVE

Version/Model Number

TLN2122EN

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

b199b4c9-7a88-4c02-96e4-b05ee484400b

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2019

Package DI Number

25051978004735

Quantity per Package

5

Contains DI Package

15051978004738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-