Catalog Number

-

Brand Name

SOLEIL

Version/Model Number

125SS

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

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

K163447,K163447,K163447,K163447

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

e0c54ad8-3a61-4f22-a3e3-b00cef2432a2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 12, 2017

Package DI Number

D838BC125SS8

Quantity per Package

4

Contains DI Package

D838BC125SS6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case