WriteSite Plus Prep Resistent Skin Marker, Regular Tip Pen Only - Intended use for surgical marking on intact skin - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Intended use for surgical marking on intact skin

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More Product Details

Catalog Number

-

Brand Name

WriteSite Plus Prep Resistent Skin Marker, Regular Tip Pen Only

Version/Model Number

2700-I

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

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

FZZ

Product Code Name

MARKER, SKIN

Device Record Status

Public Device Record Key

cbac1412-53a6-46e3-a370-235f3d759abc

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Additional Identifiers

Package DI Number

10840113231307

Quantity per Package

50

Contains DI Package

00840113231300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ASPEN SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 952
2 A medical device with a moderate to high risk that requires special controls. 494