NATURE-CRYL® - NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK - Gc America Inc.

Duns Number:005473608

Device Description: NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 1lb POWDER

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More Product Details

Catalog Number

349806

Brand Name

NATURE-CRYL®

Version/Model Number

349806

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2018

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Device Record Status

Public Device Record Key

126c910c-a36e-4408-83ae-19b884f4d7aa

Public Version Date

August 09, 2018

Public Version Number

5

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GC AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 4772