Sterion® Skin Closure - Intended for skin closure and closure support for - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Intended for skin closure and closure support for sutures and staples

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sterion® Skin Closure

Version/Model Number

753040PBX

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

K874813,K874813

Product Code Details

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Device Record Status

Public Device Record Key

f053fdb7-1a4d-4708-94d9-e339ced2badd

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

00840113225408

Quantity per Package

50

Contains DI Package

00840113225392

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