Catalog Number

-

Brand Name

Signia

Version/Model Number

SIGLU60A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160176,K160176

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

9dd824d6-f1f1-4f42-a1b1-0891a2f04db9

Public Version Date

December 07, 2021

Public Version Number

4

DI Record Publish Date

May 26, 2017

Package DI Number

20884521543505

Quantity per Package

6

Contains DI Package

10884521543508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE