Catalog Number

852-820

Brand Name

Safety Release Spring Module

Version/Model Number

852-820

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2021

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)

-

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

-

Product Code

DYJ

Product Code Name

RETAINER, SCREW EXPANSION, ORTHODONTIC

Public Device Record Key

38321872-5cfb-4587-a35b-f2e2111a28f9

Public Version Date

March 08, 2021

Public Version Number

3

DI Record Publish Date

September 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-