Catalog Number

-

Brand Name

SureForm

Version/Model Number

480545

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

f6ee4c2d-01fe-4459-b26a-0e707fe5606a

Public Version Date

December 30, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2019

Package DI Number

10886874117597

Quantity per Package

6

Contains DI Package

00886874117590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX