GoldenDent - Golden-Taper Rotary Pack - Type F3 (6 files) - - GoldenDent

Duns Number:078273228

Device Description: Golden-Taper Rotary Pack - Type F3 (6 files) - Length 21mm

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More Product Details

Catalog Number

GTF3-21

Brand Name

GoldenDent

Version/Model Number

GTF3-21

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)

-

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

64b2a3d2-1d63-4bbd-8a9a-a6aceeef813f

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GOLDENDENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 145
2 A medical device with a moderate to high risk that requires special controls. 2