Catalog Number

-

Brand Name

SureForm

Version/Model Number

48345G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

GDW

Product Code Name

Staple, implantable

Public Device Record Key

46f2e619-5920-4568-a84d-4054a89e65c1

Public Version Date

March 02, 2020

Public Version Number

3

DI Record Publish Date

March 15, 2019

Package DI Number

10886874117092

Quantity per Package

12

Contains DI Package

00886874117095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX