Catalog Number

TLSB2122EN

Brand Name

TIELLE® SILICONE BORDER

Version/Model Number

TLSB2122EN

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

fb3f37a7-2231-4c89-90b1-d4dc622212f7

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978005756

Quantity per Package

5

Contains DI Package

15051978005759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-