Henry Schein - Replacement Rails 10_EA_5460 - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Replacement Rails 10_EA_5460

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More Product Details

Catalog Number

1125460

Brand Name

Henry Schein

Version/Model Number

1125460

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)

-

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

EFW

Product Code Name

TOOTHBRUSH, MANUAL

Device Record Status

Public Device Record Key

878522a3-ec01-4d3f-be15-1299d7fc35c6

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 22, 2022

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