Catalog Number

MTL308

Brand Name

TIELLE® LITE

Version/Model Number

MTL308

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

d77dddf2-a7d1-44bf-bcca-5481786c3e00

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978000706

Quantity per Package

10

Contains DI Package

15051978000709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-