Catalog Number

-

Brand Name

SureForm

Version/Model Number

480445

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

-

Product Code

GDW

Product Code Name

Staple, implantable

Public Device Record Key

084a4ab9-722f-4252-9b99-ef4007b62cb8

Public Version Date

March 02, 2020

Public Version Number

2

DI Record Publish Date

March 15, 2019

Package DI Number

10886874117580

Quantity per Package

6

Contains DI Package

00886874117583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX