Catalog Number

tri-ban72

Brand Name

Avaline Medical NJ LLC

Version/Model Number

tri-ban72

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NEC

Product Code Name

Bandage, liquid, skin protectant

Public Device Record Key

022550c8-156e-47f1-8dbd-cea7dfb06eb3

Public Version Date

March 24, 2022

Public Version Number

2

DI Record Publish Date

March 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-