Catalog Number

BA5000.5

Brand Name

BandNet®

Version/Model Number

5000.5

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

f3b6db68-dac5-4c1e-b6b3-3bc6fa409e67

Public Version Date

January 17, 2022

Public Version Number

2

DI Record Publish Date

October 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-