SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4 - GATES DRILLS (6/pack) Length: 28mm, Size: 4, - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: GATES DRILLS (6/pack) Length: 28mm, Size: 4, Material: Stainless Steel; For more informati GATES DRILLS (6/pack) Length: 28mm, Size: 4, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23532/s/gates-glidden-drills-scott-s-select/

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More Product Details

Catalog Number

112-5344

Brand Name

SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4

Version/Model Number

112-5344

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)

-

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

30104e24-2e52-4f71-bccd-56fa2018398a

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTT'S DENTAL SUPPLY L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1050
2 A medical device with a moderate to high risk that requires special controls. 90