Catalog Number

-

Brand Name

Hualian

Version/Model Number

HLPL001

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

affe621c-f816-483d-aef7-7a045d730819

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

26970703090036

Quantity per Package

1200

Contains DI Package

16970703090022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON