Catalog Number

-

Brand Name

Keystone Keysplint Soft 1Kg

Version/Model Number

71186

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183598

Product Code

KMY

Product Code Name

Positioner, Tooth, Preformed

Public Device Record Key

6237eb5f-bcb3-4317-8212-b2038c660929

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

August 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-