Catalog Number

RR-1TSB

Brand Name

Retainer Retriever

Version/Model Number

RR-1TSB

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

-

Product Code

ECR

Product Code Name

Setter, Band, Orthodontic

Public Device Record Key

b80ea889-66f3-4944-94da-5d1098ab192a

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-