Catalog Number

-

Brand Name

SmartBands

Version/Model Number

291593

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)

-

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

95688709-0083-442c-a8e5-7a90ccbc94a0

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

December 08, 2020

Package DI Number

10789594000760

Quantity per Package

100

Contains DI Package

00789594000763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-