Catalog Number

TLSB1212EN

Brand Name

TIELLE® SILICONE BORDER

Version/Model Number

TLSB1212EN

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

0a10ecf4-cab5-4c08-8521-5eb404dea97b

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978005695

Quantity per Package

10

Contains DI Package

15051978005698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-