H-FILES - H-Files 153, 25 mm, # 80, handle SMG - FKG Dentaire Sàrl

Duns Number:482884061

Device Description: H-Files 153, 25 mm, # 80, handle SMG

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More Product Details

Catalog Number

01.153.25.080.CG

Brand Name

H-FILES

Version/Model Number

01.153.25.080.CG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code Details

Product Code

EKS

Product Code Name

File, Pulp Canal, Endodontic

Device Record Status

Public Device Record Key

8a9c02a7-7541-4258-8125-acfad43e7a13

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FKG DENTAIRE SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 200