Catalog Number

AR-19021TT-1

Brand Name

TissueTak™

Version/Model Number

AR-19021TT-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203117,K203117

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

cdcb4247-6489-47ee-8ffa-2756ccedda75

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Package DI Number

17290017155361

Quantity per Package

10

Contains DI Package

07290017155364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box