Catalog Number

RSHA454

Brand Name

Reflect Implant System

Version/Model Number

RSHA454

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)

Yes

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

K180924

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

1d81c426-1761-46a5-8cc2-ede888d73a96

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-