Henry Schein - ProPlus Cuff & Bladder, 1 Tube, Thigh, Black - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: ProPlus Cuff & Bladder, 1 Tube, Thigh, Black

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More Product Details

Catalog Number

1126091

Brand Name

Henry Schein

Version/Model Number

1126091

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

16128f32-7fd8-4bef-9df6-079491ce5e85

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10304040001865

Quantity per Package

16

Contains DI Package

00304040001868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"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