SCOTT'S HEADREST CVR STD 9.5" X 11" (250) - HEADREST COVER (250/box) Size: Regular, Color: - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: HEADREST COVER (250/box) Size: Regular, Color: Clear, Dimensions: 11" x 9-1/2"; For more i HEADREST COVER (250/box) Size: Regular, Color: Clear, Dimensions: 11" x 9-1/2"; For more information: https://www.scottsdental.com/catalog/product/view/id/23494/s/headrest-covers-disposable-poly/

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More Product Details

Catalog Number

107-5011

Brand Name

SCOTT'S HEADREST CVR STD 9.5" X 11" (250)

Version/Model Number

107-5011

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

PEM

Product Code Name

Dental barriers and sleeves

Device Record Status

Public Device Record Key

3d8bc92c-e6db-4873-8679-6925555504a2

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