GIALLOY CB/N-H - Aufbrennfähige - SRL Dental GmbH

Duns Number:313446764

Device Description: Aufbrennfähige Nichtedelmetall-Dental-Gusslegierung auf Nickel-Basis, Typ 4 / NPM Nickel-b Aufbrennfähige Nichtedelmetall-Dental-Gusslegierung auf Nickel-Basis, Typ 4 / NPM Nickel-based dental alloy for casting, type 4 Bedruckt China 25kg Eimer

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More Product Details

Catalog Number

-

Brand Name

GIALLOY CB/N-H

Version/Model Number

5890352 Bedruckt China 25kg Eimer

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

b24e9eb1-92b2-4347-945b-dcc6ad4cfd51

Public Version Date

December 07, 2018

Public Version Number

1

DI Record Publish Date

November 06, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SRL DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58