Catalog Number

4220115

Brand Name

KeySplint Soft for HeyGears

Version/Model Number

4220115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

KMY

Product Code Name

POSITIONER, TOOTH, PREFORMED

Public Device Record Key

f01c74da-9c13-4c88-bde7-f7757586ae55

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 06, 2021

Package DI Number

H66842201152

Quantity per Package

8

Contains DI Package

H66842201151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box