Catalog Number

-

Brand Name

Hualian

Version/Model Number

HL507C

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

e3be8156-c6f3-4126-85a3-c0716f32cd1d

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

26941762600214

Quantity per Package

360

Contains DI Package

16941762600200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE