Henry Schein - REPLACEMENT PAD & KEY KIT - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: REPLACEMENT PAD & KEY KIT

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More Product Details

Catalog Number

1067780

Brand Name

Henry Schein

Version/Model Number

1067780

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)

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

DZB

Product Code Name

Headgear, extraoral, orthodontic

Device Record Status

Public Device Record Key

c9d2a07b-2754-4d01-8d72-8402e2118f9d

Public Version Date

February 13, 2020

Public Version Number

1

DI Record Publish Date

February 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34