Catalog Number

349808

Brand Name

NATURE-CRYL®

Version/Model Number

349808

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

-

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

2553ee39-7d2a-44f8-a180-b054b345426d

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-