GC Fuji TRIAGE® - GC Fuji TRIAGE® Starter Package, White (1 x 50 - Gc America Inc.

Duns Number:005473608

Device Description: GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x G GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x GC CAVITY CONDITIONER, 1 x GC Fuji COAT LC)

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More Product Details

Catalog Number

439991

Brand Name

GC Fuji TRIAGE®

Version/Model Number

439991

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K013198,K013198

Product Code Details

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Device Record Status

Public Device Record Key

cb5d9353-d731-4716-90de-ff293e390c73

Public Version Date

February 07, 2019

Public Version Number

4

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