GIALLOY PA - Nichtedelmetall-Dental-Modellgusslegierung auf - SRL Dental GmbH

Duns Number:313446764

Device Description: Nichtedelmetall-Dental-Modellgusslegierung auf Kobalt-Basis, Typ 5 NPM - Cobalt-based dent Nichtedelmetall-Dental-Modellgusslegierung auf Kobalt-Basis, Typ 5 NPM - Cobalt-based dental casting alloy, type 5Neutral 25 kg Eimer

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More Product Details

Catalog Number

-

Brand Name

GIALLOY PA

Version/Model Number

5890051 Neutral 25 kg 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

f6e6df87-34a2-4730-8c4d-51ac41cb2d91

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 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