Catalog Number

-

Brand Name

Orthocryl®

Version/Model Number

161-621-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K942667

Product Code

KMY

Product Code Name

POSITIONER, TOOTH, PREFORMED

Public Device Record Key

0dd46145-cf67-45b3-a559-9d9156d6be77

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-