SCOTT'S GUTTA PERCHA PTS 120/bx CC # 40 - GUTTA PERCHA POINTS (120/box) Size: 40; For more - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: GUTTA PERCHA POINTS (120/box) Size: 40; For more information: https://www.scottsdental.com GUTTA PERCHA POINTS (120/box) Size: 40; For more information: https://www.scottsdental.com/catalog/product/view/id/23534/s/gutta-percha-points-scott-s-select/

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More Product Details

Catalog Number

103-9013

Brand Name

SCOTT'S GUTTA PERCHA PTS 120/bx CC # 40

Version/Model Number

103-9013

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

EKM

Product Code Name

GUTTA-PERCHA

Device Record Status

Public Device Record Key

41563c19-9e10-44e2-9f46-e8a7478b63ca

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