Straight Drill with Stopper without Irrigation - 3.0 mm Straight Drill with Stopper without - SURGIKOR, LLC

Duns Number:080321629

Device Description: 3.0 mm Straight Drill with Stopper without Irrigation Ø3.0 mm x L13.0mm

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More Product Details

Catalog Number

-

Brand Name

Straight Drill with Stopper without Irrigation

Version/Model Number

SDST3013

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

-

Product Code Details

Product Code

DZA

Product Code Name

Drill, Dental, Intraoral

Device Record Status

Public Device Record Key

2e26d563-f715-4ce2-81ef-ec9094dfe9cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGIKOR, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 297
2 A medical device with a moderate to high risk that requires special controls. 636