Catalog Number

349804

Brand Name

NATURE-CRYL®

Version/Model Number

349804

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 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

-

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

K051358

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

154118cf-e82a-4a47-96ae-754b14b4e59e

Public Version Date

August 09, 2018

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-