Henry Schein - Strip Wound Closure Opague - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Strip Wound Closure Opague

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More Product Details

Catalog Number

9004314

Brand Name

Henry Schein

Version/Model Number

9004314

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Device Record Status

Public Device Record Key

e743b0ab-4a3e-40e5-8183-1d233d6e8fb7

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Additional Identifiers

Package DI Number

H65890043142

Quantity per Package

4

Contains DI Package

H65890043141

Package Discontinue Date

-

Package Status

In Commercial Distribution

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