Catalog Number

351210

Brand Name

Ho Band

Version/Model Number

351210

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

6175c99d-4a40-4627-b554-09656eb8647a

Public Version Date

October 05, 2022

Public Version Number

5

DI Record Publish Date

December 08, 2020

Package DI Number

10789594000968

Quantity per Package

100

Contains DI Package

00789594000961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package