Catalog Number

855-262A

Brand Name

Kilroy Spring

Version/Model Number

855-262A

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)

-

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

ECO

Product Code Name

Spring, Orthodontic

Public Device Record Key

4899ca9b-e31f-4f40-95a7-56e44a9b3c7b

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

April 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-